Performance and Safety of the ANTALGEEK® Thess Monitoring Medical Device in the Outpatient Management of Acute Pain and Postoperative Recovery (TRACE)

Evaluation of the Performance and Safety of the ANTALGEEK® Thess Monitoring Medical Device in the Outpatient Management of Acute Pain and Postoperative Recovery - A Single-Center, Randomized, Controlled Proof-of-Concept Study.

Acute postoperative pain (APOP) is a major public health problem, affecting nearly 10 million patients in France each year. Effective analgesic therapy in the first postoperative week is a key factor in reducing early postoperative morbidity and mortality. Poorly controlled APOP is a major risk factor for chronic postoperative pain. In France today, more and more patients undergo surgical procedures as outpatients. The challenge is to manage postoperative pain in the homes of patients who have undergone increasingly complex surgical procedures, either after outpatient surgery or after a prompt return home as part of an Enhanced Recovery After Surgery (ERAS) protocol. In outpatient surgery, postoperative pain management requires new strategies and/or organizational approaches to ensure high-quality pain management from the very start. The principle of analgesia for acute postoperative pain recommends: i) routine, fixed-schedule maintenance therapy; and ii) rescue therapy if maintenance therapy is insufficient, based on pain titration, using mild or strong oral opioids. Postoperative pain is the primary focus of postoperative care but the goal is also to improve postoperative recovery and enhance the patient's overall care. To date, there are no medical telemonitoring devices to support the patient in properly taking their analgesics based on multiple-daily assessments of the efficacy and tolerability of the analgesic treatment, enabling systematic postoperative screening for early and late warning signs of the risk of chronic pain. The Thess Monitoring device, which implements the ANTALGEEK® protocol, (TMA) was developed to optimize the efficiency of outpatient management of acute postoperative pain. It improves patients' adherence to maintenance treatment with adaptive, personalized control of analgesia through better use of opioid rescue therapy, and the reduction of adverse effects associated with improper opioid use (under- or over-dosing). The aim is to ensure optimal pain resolution and improve early and late postoperative recovery during the first postoperative week. The TMA system enables remote monitoring of the efficacy and tolerability of analgesic treatment, as well as early and late warning signs of the risk of chronic pain. By measuring pain scores daily during the first postoperative week, it identifies patients with a suboptimal pain trajectory who are at high risk of developing persistent pain beyond the third month. It also assesses warning signs of the risk of chronic pain (neuropathic pain, persistent opioid use) at intervals following the procedure (Day 8, Month 1, Month 2, Month 3). Improving the patient care pathway via the TMA system should make it possible to better coordinate postoperative follow-up between hospital-based and community-based care.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Post Operative Pain
• Intervention / Treatment: Device: Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocol

Detailed Description

The problem of acute postoperative pain (APOP) is a major public health problem, affecting nearly 10 million patients in France each year and potentially leading to numerous complications when inadequately managed. In the postoperative period, the implementation of effective analgesic therapy is a key factor in reducing early postoperative morbidity and mortality. Furthermore, poorly controlled PPS is one of the major risk factors for the development of chronic postoperative pain (CPOP). Optimizing analgesic medication to prevent an abnormal pain trajectory during the first postoperative week is a key strategy for preventing CSCP.

Today, within the French healthcare system, an increasing number of patients undergo surgical procedures performed on an outpatient basis. We are now faced with the challenge of managing postoperative pain in the homes of patients who have undergone increasingly complex surgical procedures, either following outpatient surgery or after an early return home as part of an Enhanced Recovery After Surgery (ERAS) protocol.

In outpatient surgery, improving postoperative pain management requires the implementation of new strategies and/or organizational approaches to ensure a high-quality pain management pathway from the very beginning.

The principle of analgesia for acute postoperative pain recommends a combination of: i) routine, fixed-schedule maintenance therapy; and ii) rescue therapy-if maintenance therapy is insufficient-based on the principle of pain titration, using oral opioids (mild or strong). While postoperative pain remains the primary focus of postoperative care, the goal is also to improve postoperative recovery more broadly and thereby enhance the patient's overall care.

The assessment of postoperative recovery in outpatient surgery patients using a medical telemonitoring device is associated with a reduction in discomfort caused by various postoperative symptoms, including postoperative pain. However, to date, there is no medical telemonitoring device that both supports the patient in properly taking their analgesics based on multiple-daily assessments of the efficacy and tolerability of the analgesic treatment, and enables systematic postoperative screening for early and late warning signs of the risk of chronic pain.

To this end, the Thess Monitoring medical telemonitoring device (which implements the ANTALGEEK® protocol) (TMA) was developed. It is a tool for continuous therapeutic support and postoperative telemonitoring designed to optimize the efficiency of outpatient management of acute postoperative pain in patients by improving adherence to maintenance therapy, adaptive and personalized control of analgesia through better use of opioid rescue therapy, and the reduction of adverse effects associated with improper opioid use (under- or over-dosing), with the goal of ensuring optimal pain resolution and improved early and late postoperative recovery during the first postoperative week (D0-D7). To achieve this, the TMA system enables remote monitoring of the efficacy and tolerability of analgesic treatment, as well as early and late warning signs of the risk of chronic pain: identify, through daily measurement of pain scores during the first postoperative week, patients with a suboptimal pain trajectory who are at high risk of developing persistent postoperative pain beyond the third month; assess warning signs of the risk of chronic pain (neuropathic pain, persistent opioid use) at intervals following the procedure (Day 8, Month 1, Month 2, Month 3).

Improving the patient care pathway through the TMA system should thus make it possible to better coordinate postoperative follow-up between hospital-based and community-based care.

In this initial proof-of-concept study, the investigators aim to evaluate the performance and safety of the TMA medical device in the outpatient management of acute pain during the first postoperative week, as well as its impact on postoperative recovery and on reducing the risk of pain becoming chronic by the third postoperative month.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anissa MEGZARI; Phone Number: 0466684236; Email: drc@chu-nimes.fr
• Study Contact Backup: Name: Joël LHERMITE, Dr.; Phone Number: +334.66.68.30.50; Email: joel.lhermite@chu-nimes.fr

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30029
      • Recruiting
      • Nimes University Hospital
      • Contact: Anissa MEGZARI; Phone Number: +33466684236; Email: drc@chu-nimes.fr
      • Contact: Nimes U Hospital, Dr.; Phone Number: +334.66.68.30.50; Email: joel.lhermite@chu-nimes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients eligible for outpatient surgery.
• Patients undergoing surgery likely to result in moderate to severe pain.
• Patients available for a 3-month follow-up.
• Patients who have provided their free and informed consent.
• Patients who have signed the consent form.
• Patients enrolled in or covered by a health insurance plan.

Exclusion Criteria:

• Patients participating in an interventional RIPH study involving a drug or classified as Category 1.
• Patients in an exclusion period determined by another study.
• Patients under judicial protection, guardianship, or conservatorship.
• Patients unable to express consent.
• Patient for whom it is impossible to provide informed information.
• Pregnant, laboring, or breastfeeding patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Postoperative pain management : standard care; Patients receiving standard postoperative analgesic care
Experimental: Postoperative pain management using the Thess telemonitoring device; Patients being monitored with the Thess Monitoring medical telemonitoring device in conjunction with the ANTALGEEK® protocol	Device: Post-operative follow-up using the Thess Telemonitoring device in conjunction with the ANTALGEEK® protocol; The Thess monitoring medical device (Thess Corp., Montpellier) uses the remote ANTALGEEK® telemonitoring protocol to manage pain in outpatients who have had surgery causing moderate-to-severe pain. It digitalizes and optimizes acute postoperative pain management at home by improving adherence to maintenance therapy, with adaptive, tailored control of analgesia through better use of opioid rescue therapy to reduce the adverse effects of opioid misuse and ensures optimal pain resolution and postoperative recovery during the first week. The ANTALGEEK decision-making algorithm and a medical telemonitoring protocol help patients follow their pain medication regimen, monitoring them in postoperative Week 1, based on the preoperative prescription, data on the patient's adherence to treatment, its efficacy and tolerability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the experimental group	The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90	Day 2
Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the standard care (control) group.	The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90	Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group	The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90	Day 1, before the intervention
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group	The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90	Day 1, after the intervention
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group	The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90	Day 7
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group	The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90	Day 1, before the intervention
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group	The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90	Day 1, after the intervention
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group	The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being. The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient). Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome). The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery). Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90	Day 7
Pain progression in the experimental group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 1
Pain progression in the experimental group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 2
Pain progression in the experimental group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 3
Pain progression in the experimental group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 4
Pain progression in the experimental group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 5
Pain progression in the experimental group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 6
Pain progression in the experimental group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 7
Pain progression in the experimental group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Month 1
Pain progression in the experimental group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Month 2
Pain progression in the experimental group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Month 3
Pain progression in the in the standard care (control) group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 1
Pain progression in the in the standard care (control) group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 2
Pain progression in the in the standard care (control) group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 3
Pain progression in the in the standard care (control) group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 4
Pain progression in the in the standard care (control) group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 5
Pain progression in the in the standard care (control) group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 6
Pain progression in the in the standard care (control) group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Day 7
Pain progression in the in the standard care (control) group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Month 1
Pain progression in the in the standard care (control) group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Month 2
Pain progression in the in the standard care (control) group	Average pain score over 24 hours according to the Visual Analog Scale (0 -10)	Month 3
Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group	Patient's declaration in the Thess Monitoring Application	Day 0
Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group	Phone call from the patient	Day 0
Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group	Patient's declaration in the Thess Monitoring Application	Day 1
Adherence to the standard pain management regimen (non-opioid analgesics) in the in the standard care (control) group	Phone call from the patient	Day 1
Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group	Patient's declaration in the Thess Monitoring Application	Day 2
Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group	Phone call from the patient	Day 2
Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group	Patient's declaration in the Thess Monitoring Application	Day 3
Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group	Phone call from the patient	Day 3
Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group	Patient's declaration in the Thess Monitoring Application	Day 4
Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group	Phone call from the patient	Day 4
Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group	Patient's declaration in the Thess Monitoring Application	Day 5
Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group	Phone call from the patient	Day 5
Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group	Patient's declaration in the Thess Monitoring Application	Day 6
Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group	Phone call from the patient	Day 6
Adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group	Patient's declaration in the Thess Monitoring Application	Day 7
Adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group	Phone call from the patient	Day 7
Incidence of adverse effects associated with opioid use in the experimental group	Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 0
Incidence of adverse effects associated with opioid use in the standard care (control) group	Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 0
Incidence of adverse effects associated with opioid use in the experimental group	Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 1
Incidence of adverse effects associated with opioid use in the standard care (control) group	Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 1
Incidence of adverse effects associated with opioid use in the experimental group	Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 2
Incidence of adverse effects associated with opioid use in the standard care (control) group	Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 2
Incidence of adverse effects associated with opioid use in the experimental group	Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 3
Incidence of adverse effects associated with opioid use in the standard care (control) group	Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 3
Incidence of adverse effects associated with opioid use in the experimental group	Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 4
Incidence of adverse effects associated with opioid use in the standard care (control) group	Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 4
Incidence of adverse effects associated with opioid use in the experimental group	Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 5
Incidence of adverse effects associated with opioid use in the standard care (control) group	Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 5
Incidence of adverse effects associated with opioid use in the experimental group	Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 6
Incidence of adverse effects associated with opioid use in the standard care (control) group	Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 6
Incidence of adverse effects associated with opioid use in the experimental group	Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 7
Incidence of adverse effects associated with opioid use in the standard care (control) group	Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no	Day 7
Safety in the experimental group	Qualitative assessment. Any adverse events of any cause related to treatment will be recorded in the electronic clinical registration form following a phone call to the patient.	Day 7
Safety in the standard care (control) group	Qualitative assessment. Any adverse events of any cause related to treatment will be recorded in the electronic clinical registration form following a phone call to the patient.	Day 7
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application	Day 1
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form	Day 1
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application	Day 2
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical monitoring form	Day 2
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application	Day 3
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form	Day 3
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application	Day 4
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form	Day 4
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application	Day 5
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form	Day 5
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application	Day 6
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form	Day 6
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application	Day 7
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical monitoring form	Day 7
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application and a phone call to the patient	Month 1
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form and a phone call to the patient	Month 1
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application and a phone call to the patient	Month 3
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group	Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection on the electronic clinical registration form and a phone call to the patient	Month 3
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group	Data collection via the Tess Monitoring Application	Day 1
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group	Data collection on the electronic clinical registration form	Day 1
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group	Data collection via the Tess Monitoring Application	Day 2
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group	Data collection on the electronic clinical registration form	Day 2
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group	Data collection via the Tess Monitoring Application	Day 3
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group	Data collection on the electronic clinical registration form	Day 3
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group	Data collection via the Tess Monitoring Application	Day 4
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group	Data collection on the electronic clinical registration form	Day 4
Prescription issued outside of those prescribed upon hospital discharge in the experimental group	Quantitative	Month 3
Prescription issued outside of those prescribed upon hospital discharge in the standard care(control) group	Quantitative	Month 3
Number of days of sick leave prescribed in the experimental group	Quantitative	Month 3
Number of days of sick leave prescribed in the standard care (control) group	Quantitative	Month 3
Satisfaction questionnaire administered to the patient in the experimental group	Qualitative	Day 3
Satisfaction questionnaire administered to the patient in the standard care (control) group	Qualitative	Day 3
Satisfaction questionnaire administered to the anesthesiologist in the experimental group	Qualitative	End of the inclusion period
Satisfaction questionnaire administered to the anesthesiologist in the standard care (control) group	Qualitative	End of the inclusion period
System Usability Scale score during the follow-up call to patients in the experimental group	The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items. Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale. The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item. This scoring system allows the assessment of user satisfaction and the overall usability of the system.	Day 30
System Usability Scale score from health providers to the experimental group	The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items. Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale. The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item. This scoring system allows the assessment of user satisfaction and the overall usability of the system.	End of the inclusion period
System Usability Scale score during the follow-up call to patients in the standard care (control) group	The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items. Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale. The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item. This scoring system allows the assessment of user satisfaction and the overall usability of the system.	Day 30
System Usability Scale score from health providers to the standard care (control) group	The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items. Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale. The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item. This scoring system allows the assessment of user satisfaction and the overall usability of the system.	End of the inclusion period
DN2 questionnaire score in the experimental group	The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.	Post-operative Month 1
DN2 questionnaire score in the experimental group	The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.	Post-operative Month 2
DN2 questionnaire score in the experimental group	The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.	Post-operative Month 3
DN2 questionnaire score in the standard care (control) group	The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.	Post-operative Month 1
DN2 questionnaire score in the standard care (control) group	The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.	Post-operative Month 2
DN2 questionnaire score in the standard care (control) group	The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group. It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching. The cutoff for a positive DN2 result is set at 3 out of 7 points. A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.	Post-operative Month 3
Collection of incidents, malfunctions, and organization deviations that occurred during implementation in the experimental group	Qualitative	Month 3
Time spent connected to the Thess Monitoring device per patient in the experimental group	Qualitative	Month 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
• Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available.
• Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
• Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, Cunin G, Fermanian J, Ginies P, Grun-Overdyking A, Jafari-Schluep H, Lanteri-Minet M, Laurent B, Mick G, Serrie A, Valade D, Vicaut E. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain. 2005 Mar;114(1-2):29-36. doi: 10.1016/j.pain.2004.12.010. Epub 2005 Jan 26.
• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
• Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.
• Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
• Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.
• Smith WC, Bourne D, Squair J, Phillips DO, Chambers WA. A retrospective cohort study of post mastectomy pain syndrome. Pain. 1999 Oct;83(1):91-5. doi: 10.1016/s0304-3959(99)00076-7.
• Herrmann C. International experiences with the Hospital Anxiety and Depression Scale--a review of validation data and clinical results. J Psychosom Res. 1997 Jan;42(1):17-41. doi: 10.1016/s0022-3999(96)00216-4.
• Johansen A, Romundstad L, Nielsen CS, Schirmer H, Stubhaug A. Persistent postsurgical pain in a general population: prevalence and predictors in the Tromso study. Pain. 2012 Jul;153(7):1390-1396. doi: 10.1016/j.pain.2012.02.018. Epub 2012 Mar 24.
• Lavand'homme PM, Grosu I, France MN, Thienpont E. Pain trajectories identify patients at risk of persistent pain after knee arthroplasty: an observational study. Clin Orthop Relat Res. 2014 May;472(5):1409-15. doi: 10.1007/s11999-013-3389-5.
• Myles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
• Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.
• Lavand'homme P. The progression from acute to chronic pain. Curr Opin Anaesthesiol. 2011 Oct;24(5):545-50. doi: 10.1097/ACO.0b013e32834a4f74.
• Chaves JF, Brown JM. Spontaneous cognitive strategies for the control of clinical pain and stress. J Behav Med. 1987 Jun;10(3):263-76. doi: 10.1007/BF00846540.
• Attal N, Lanteri-Minet M, Laurent B, Fermanian J, Bouhassira D. The specific disease burden of neuropathic pain: results of a French nationwide survey. Pain. 2011 Dec;152(12):2836-2843. doi: 10.1016/j.pain.2011.09.014. Epub 2011 Oct 20.
• Parsons B, Schaefer C, Mann R, Sadosky A, Daniel S, Nalamachu S, Stacey BR, Nieshoff EC, Tuchman M, Anschel A. Economic and humanistic burden of post-trauma and post-surgical neuropathic pain among adults in the United States. J Pain Res. 2013 Jun 17;6:459-69. doi: 10.2147/JPR.S44939. Print 2013.
• Althaus A, Hinrichs-Rocker A, Chapman R, Arranz Becker O, Lefering R, Simanski C, Weber F, Moser KH, Joppich R, Trojan S, Gutzeit N, Neugebauer E. Development of a risk index for the prediction of chronic post-surgical pain. Eur J Pain. 2012 Jul;16(6):901-10. doi: 10.1002/j.1532-2149.2011.00090.x. Epub 2011 Dec 23.
• VanDenKerkhof EG, Hopman WM, Goldstein DH, Wilson RA, Towheed TE, Lam M, Harrison MB, Reitsma ML, Johnston SL, Medd JD, Gilron I. Impact of perioperative pain intensity, pain qualities, and opioid use on chronic pain after surgery: a prospective cohort study. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):19-27. doi: 10.1097/AAP.0b013e318237516e.
• Martinez V, Baudic S, Fletcher D. [Chronic postsurgical pain]. Ann Fr Anesth Reanim. 2013 Jun;32(6):422-35. doi: 10.1016/j.annfar.2013.04.012. Epub 2013 Jun 7. French.
• Rosenstiel AK, Keefe FJ. The use of coping strategies in chronic low back pain patients: relationship to patient characteristics and current adjustment. Pain. 1983 Sep;17(1):33-44. doi: 10.1016/0304-3959(83)90125-2.
• Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15.
• Rothaug J, Zaslansky R, Schwenkglenks M, Komann M, Allvin R, Backstrom R, Brill S, Buchholz I, Engel C, Fletcher D, Fodor L, Funk P, Gerbershagen HJ, Gordon DB, Konrad C, Kopf A, Leykin Y, Pogatzki-Zahn E, Puig M, Rawal N, Taylor RS, Ullrich K, Volk T, Yahiaoui-Doktor M, Meissner W. Patients' perception of postoperative pain management: validation of the International Pain Outcomes (IPO) questionnaire. J Pain. 2013 Nov;14(11):1361-70. doi: 10.1016/j.jpain.2013.05.016. Epub 2013 Sep 7.
• Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J (Clin Res Ed). 1986 Feb 1;292(6516):344. doi: 10.1136/bmj.292.6516.344. No abstract available.
• Hinrichs-Rocker A, Schulz K, Jarvinen I, Lefering R, Simanski C, Neugebauer EA. Psychosocial predictors and correlates for chronic post-surgical pain (CPSP) - a systematic review. Eur J Pain. 2009 Aug;13(7):719-30. doi: 10.1016/j.ejpain.2008.07.015. Epub 2008 Oct 25.
• Myles PS, Myles DB. An Updated Minimal Clinically Important Difference for the QoR-15 Scale. Anesthesiology. 2021 Nov 1;135(5):934-935. doi: 10.1097/ALN.0000000000003977. No abstract available.
• Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
• Maguire MF, Latter JA, Mahajan R, Beggs FD, Duffy JP. A study exploring the role of intercostal nerve damage in chronic pain after thoracic surgery. Eur J Cardiothorac Surg. 2006 Jun;29(6):873-9. doi: 10.1016/j.ejcts.2006.03.031. Epub 2006 May 3.
• Allvin R, Berg K, Idvall E, Nilsson U. Postoperative recovery: a concept analysis. J Adv Nurs. 2007 Mar;57(5):552-8. doi: 10.1111/j.1365-2648.2006.04156.x.
• Atkins RM, Duckworth T, Kanis JA. Algodystrophy following Colles' fracture. J Hand Surg Br. 1989 May;14(2):161-4. doi: 10.1016/0266-7681_89_90118-6.
• Bonnet A, Lavand'homme P, France MN, Reding R, De Kock M. [Postoperative pain trajectories to identify risk of chronic postsurgical pain in living donors for liver transplantation]. Ann Fr Anesth Reanim. 2012 Dec;31(12):945-9. doi: 10.1016/j.annfar.2012.09.011. Epub 2012 Oct 30. French.
• Chapman CR, Donaldson G, Davis J, Ericson D, Billharz J. Postoperative pain patterns in chronic pain patients: a pilot study. Pain Med. 2009 Apr;10(3):481-7. doi: 10.1111/j.1526-4637.2008.00522.x. Epub 2008 Nov 5.
• Chapman CR, Davis J, Donaldson GW, Naylor J, Winchester D. Postoperative pain trajectories in chronic pain patients undergoing surgery: the effects of chronic opioid pharmacotherapy on acute pain. J Pain. 2011 Dec;12(12):1240-6. doi: 10.1016/j.jpain.2011.07.005. Epub 2011 Oct 26.
• de Mos M, de Bruijn AG, Huygen FJ, Dieleman JP, Stricker BH, Sturkenboom MC. The incidence of complex regional pain syndrome: a population-based study. Pain. 2007 May;129(1-2):12-20. doi: 10.1016/j.pain.2006.09.008. Epub 2006 Nov 7.
• Duale C, Ouchchane L, Schoeffler P; EDONIS Investigating Group; Dubray C. Neuropathic aspects of persistent postsurgical pain: a French multicenter survey with a 6-month prospective follow-up. J Pain. 2014 Jan;15(1):24.e1-24.e20. doi: 10.1016/j.jpain.2013.08.014. Epub 2013 Oct 25.
• Harden NR, Bruehl S, Stanos S, Brander V, Chung OY, Saltz S, Adams A, Stulberg DS. Prospective examination of pain-related and psychological predictors of CRPS-like phenomena following total knee arthroplasty: a preliminary study. Pain. 2003 Dec;106(3):393-400. doi: 10.1016/j.pain.2003.08.009.
• Kehlet H. Surgical stress: the role of pain and analgesia. Br J Anaesth. 1989 Aug;63(2):189-95. doi: 10.1093/bja/63.2.189. No abstract available.
• Krakowski I, Theobald S, Balp L, Bonnefoi MP, Chvetzoff G, Collard O, Collin E, Couturier M, Delorme T, Duclos R, Eschalier A, Fergane B, Larue F, Magnet M, Minello C, Navez ML, Richard A, Richard B, Rostaing-Rigattieri S, Rousselot H, Santolaria N, Torloting G, Toussaint S, Vuillemin N, Wagner JP, Fabre N; FNCLCC. Summary version of the Standards, Options and Recommendations for the use of analgesia for the treatment of nociceptive pain in adults with cancer (update 2002). Br J Cancer. 2003 Aug;89 Suppl 1(Suppl 1):S67-72. doi: 10.1038/sj.bjc.6601086. No abstract available.
• Lepine JP, Godchau M, Brun P, Lemperiere T. [Evaluation of anxiety and depression among patients hospitalized on an internal medicine service]. Ann Med Psychol (Paris). 1985 Feb;143(2):175-89. No abstract available. French.
• Tsui SL, Law S, Fok M, Lo JR, Ho E, Yang J, Wong J. Postoperative analgesia reduces mortality and morbidity after esophagectomy. Am J Surg. 1997 Jun;173(6):472-8. doi: 10.1016/s0002-9610(97)00014-7.
• Myles PS, Hunt JO, Fletcher H, Solly R, Woodward D, Kelly S. Relation between quality of recovery in hospital and quality of life at 3 months after cardiac surgery. Anesthesiology. 2001 Oct;95(4):862-7. doi: 10.1097/00000542-200110000-00013.
• Rawal N, Berggren L. Organization of acute pain services: a low-cost model. Pain. 1994 Apr;57(1):117-123. doi: 10.1016/0304-3959(94)90115-5.
• Untas A, Aguirrezabal M, Chauveau P, Leguen E, Combe C, Rascle N. [Anxiety and depression in hemodialysis: validation of the Hospital Anxiety and Depression Scale (HADS)]. Nephrol Ther. 2009 Jun;5(3):193-200. doi: 10.1016/j.nephro.2009.01.007. Epub 2009 Apr 5. French.
• Woolf CJ. Generation of acute pain: central mechanisms. Br Med Bull. 1991 Jul;47(3):523-33. doi: 10.1093/oxfordjournals.bmb.a072490.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Monitoring; Pain Management; Post Operative Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Chronic Pain; Agnosia
• Other Study ID Numbers: IDIL/2024/JL01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No