Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months (ETADOL)

Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months: a Single-center Prospective Cohort Study

The effective management of acute postoperative pain remains a daily challenge despite the organizational efforts made and the techniques put in place.

Thirty percent of patients who undergo surgery suffer from chronic post-surgical pain, of which 5 to 10% are of severe intensity. Many preoperative, intraoperative, and postoperative factors, related to the patient, the surgical procedure, or the anesthetic technique, have been incriminated as risk factors for chronic post-surgical pain. The severity of acute postoperative pain is recognized as one of the risk factors for the occurrence of chronic post-surgical pain on which we can hope to interact during the peri-operative period.

In this cohort study, we wish to define the typologies of postoperative pain trajectories observed from Day 0 to Day 7 and to estimate the proportion of patients with an abnormal resolution of pain in a model of organization such as that of our institution, in classic hospitalization and in ambulatory care.

Study Overview

• Status: Recruiting
• Conditions: Pain; Chronic Pain; Surgical Procedures, Operative
• Intervention / Treatment: Other: In hospital pain evaluation; Other: In hospital questionnaires; Other: Telephone contact at 3 months

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Joël L'Hermite, MD; Phone Number: +33.(0)4.66.68.36.18; Email: joel.lhermite@chu-nimes.fr

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • Recruiting
    • CHRU de Nîmes - Hôpital Universitaire Carémeau
    • Principal Investigator: Joël L'Hermite, MD
    • Sub-Investigator: Philippe Cuvillon, MD, PhD
    • Sub-Investigator: Nathalie Vialles, MD
    • Sub-Investigator: Mathieu Briere, MD
    • Sub-Investigator: Benjamin Garnaud, MD
    • Sub-Investigator: Gauthier Buzançais, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population consists of adult surgery patients at the Nîmes University Hospital, with recruitment based on the operating theater program ffor a predefined list of surgeries.

Description

Inclusion Criteria:

• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 3 months of follow-up
• The patient has undergone a planned surgical procedure in one of the participating departments
• The patient is willing and able to respond to the study questionnaires

Exclusion Criteria:

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• It is impossible to correctly inform the patient
• Patient admitted to the ICU and still intubated at day 1

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The study population; The study population consists of adult surgery patients at the Nîmes University Hospital, with recruitment based on the operating theater program and for a predefined list of surgeries.	Other: In hospital pain evaluation; Patients will evaluate their pain levels via a verbal numerical scale on days 1(or-1), 2, 3, 4, 5, 6 & 7.; Other: In hospital questionnaires; Patients are required to fill out the PCS questionnaire between on day -1 or +1.; Other: Telephone contact at 3 months; Patients will be contacted at 3 months post-surgery for pain questionnaires DN4 and EQ5D5L.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The pain trajectory for the first 7 post-operative days.	The pain trajectory is the change in pain level evaluated by verbal numerical pain (from 0 to 10) from day 0 (surgery) to day 7.	Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The DN4 questionnaire	The Douleur Neuropathique 4 (DN4) questionnaire was developed by the French Neuropathic Pain Group and is a simple and objective tool, with the ability to distinguish nociceptive from neuropathic pain	month 3
The EuroQuol EQ5D5L questionnaire	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	month 3
Since the surgery, do you have persistent pain? yes/no	Since the surgery, do you have persistent pain? yes/no	month 3
Verbal numerical scale for pain (ranging from 0 to 10)	Verbal numerical scale for pain (ranging from 0 to 10)	month 3
Have you had complications from your surgery? yes/no	Have you had complications from your surgery? yes/no	month 3
Pain Catastrophizing Scale (PCS)	The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.	day -1 or day +1
Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day -1 or day +1
Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day 2
Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day 3
Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day 4
Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day 5
Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day 6
Cumulative consumption of antalgic drugs	Cumulative consumption of antalgic drugs	day 7

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Joël L'Hermite, MD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• 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.
• Sullivan, M. J., Bishop, S. R., & Pivik, J. The pain catastrophizing scale: development and validation. Psychological assessment, 1995, 7(4), 524.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Anticipated): February 23, 2024
• Study Completion (Anticipated): May 23, 2024

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: pain trajectory
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: LOCAL/2020/PC-02; 2020-A03223-36 (Other Identifier: RCB number)

Drug and device information, study documents

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