Help With Early Detection of Postoperative Neuropathic Pain Using SMS After Ambulatory Surgery (SMS DPpostop)

October 31, 2022 updated by: Groupe Hospitalier Paris Saint Joseph

Chronic post-operative pain is generally defined by persistent pain more than 2 months after surgery. General reviews on chronic post-operative pain describe an overall incidence of 30%, of which 5 to 10% are described as severe. Different risk factors have been identified: pain and preoperative opioid use, anxiety - depression, catastrophism, type of surgery, intensity and duration of postoperative pain, genetic factors.

If postoperative pain is essentially pain caused by excess nociceptive stimulation, investigators realize that a neuropathic component is far from being exceptional and that this can be demonstrated quickly after surgery. In addition, these neuropathic pains respond little or no to the usual analgesics and in particular to opioids, which can be the cause of misuse or death from overdose. Early detection of pain of a neuropathic nature would allow appropriate therapy to be put in place and may therefore reduce the risk of chronic postoperative pain.

The concept of ambulatory surgery assumes that postoperative pain will be minimal and can be controlled at home by the administration of oral pain relievers. However, following the development of surgical techniques and the improvement in the quality of care, the number and complexity of procedures that can be performed in ambulatory surgery have increased considerably. Consequently, a significant number of patients will probably develop chronic post-operative pain without the possibility of early detection. The prevalence of chronic post-operative pain in ambulatory surgery has been studied by a single team. The authors conclude that it is underestimated and variable depending on the surgery between 15 and 32%.

For the past few years, the GHPSJ has been using an ambulatory surgery algorithm that sends SMS messages to warn and follow up on patients. The principle is simple: patients scheduled for outpatient surgery receive text messages the day before their intervention to remind them of the instructions to be followed and the meeting times and, the day after the operation, the algorithm sends SMS to ask patients if all is well or if they have pain, nausea or vomiting, discharge from the scar. In postoperative monitoring, this technology has shown promising results.

This technology has not been used in the screening of persistent pain. The objective of this work is to assess the effectiveness of an SMS algorithm in the early detection of postoperative neuropathic pain after surgery performed on an outpatient basis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Groupe Hospitalier Paris Saint-Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient aged ≥ 18 years
  • Patient hospitalized on an outpatient basis within the Paris Saint Joseph Hospital Group in the following different surgical specialties: orthopedics, digestive, vascular, gynecological, plastic and restorative
  • French speaking patient
  • Patient with smartphone
  • Patient affiliated to a social security scheme
  • Patient having given oral, free, informed and express consent

Exclusion Criteria:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic post-operative pain

7 days after the intervention, the patient receives a standardized questionnaire by SMS, to determine whether the patient has pain at the operating site and whether this pain has the characteristics of neuropathic pain. After replying to the SMS, the patient will be contacted by phone to assess: the intensity of pain at the operating site using a numerical scale and the existence of neuropathic pain. Depending on the responses received by SMS and/or phone, a consultation appointment with an anesthesiologist specializing in pain may be offered within a maximum of 2 weeks.

Ninety days after your surgery, the patient receives the same standardized questionnaire by SMS. The patient will be contacted by telephone, in order to assess the intensity of pain at the operating site and the existence of neuropathic pain using. If the patient has post-operative pain, a consultation appointment with an anesthesiologist specializing in pain will be offered to him within a maximum of 2 weeks.
Diagnostic test: SMS in the early detection of postoperative neuropathic pain

7 days after the intervention, the patient receives a standardized questionnaire by SMS, to determine whether the patient has pain at the operating site and whether this pain has the characteristics of neuropathic pain. After replying to the SMS, the patient will be contacted by phone to assess: the intensity of pain at the operating site using a numerical scale and the existence of neuropathic pain. Depending on the responses received by SMS and/or phone, a consultation appointment with an anesthesiologist specializing in pain may be offered within a maximum of 2 weeks.

Ninety days after your surgery, the patient receives the same standardized questionnaire by SMS. The patient will be contacted by telephone, in order to assess the intensity of pain at the operating site and the existence of neuropathic pain using. If the patient has post-operative pain, a consultation appointment with an anesthesiologist specializing in pain will be offered to him within a maximum of 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnostic method
Time Frame: Day 7
This outcome corresponds to the calculation of the sensitivity and the specificity of the diagnostic method tested which is the combination of SMS and the DN2 questionnaire.
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistent post-surgical pain day 90
Time Frame: Day 90
This oucome correspond to corresponds to the proportion of patients with persistent post-surgical pain at seven days after surgery performed on an outpatient basis.
Day 90
Neuropathic pain day90
Time Frame: Day 90
This outcome correspond to the proportion of neuropathic pain on Day90 estimated using the questionnaires DN4 and NPSI during the postoperative pain consultation.
Day 90
signs suggestive of neuropathic pain day90
Time Frame: Day 90
This outcome correspond to the proportion of patients with signs suggestive of neuropathic pain during the consultation carried out by an anesthesiologist specialized in pain 90 days after the intervention.
Day 90
Comparison of pain between day7 and day90
Time Frame: Day90
This outcome corresponds to the comparison of the proportion of patients with signs suggestive of neuropathic pain during the consultation carried out by an anesthesiologist specialized in pain between Day7 and Day90 after the intervention.
Day90
Proportion of patients presenting signs suggestive of pain
Time Frame: Day90
This ouctome corresponds to the proportion of patients presenting signs suggestive of neuropathic pain during the consultation carried out by an anesthesiologist specialized in pain on Day90 who had presented pain on Day7.
Day90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Frederic ADAM, MD, Groupe hospitalier Paris saint Joseph

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2020

Primary Completion (Actual)

July 7, 2022

Study Completion (Actual)

October 28, 2022

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

November 1, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMS DPpostop

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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