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

NCT05326737 | Unknown

• 2 other identifiers: LOCAL/2020/PC-022020-A03223-36
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Procedures, Operative; Pain; Chronic Pain

Keywords

pain trajectory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• The DN4 questionnaire

  month 3

• The EuroQuol EQ5D5L questionnaire

  month 3

• Since the surgery, do you have persistent pain? yes/no

  month 3

• Verbal numerical scale for pain (ranging from 0 to 10)

  month 3

• Have you had complications from your surgery? yes/no

  month 3

Study Arms (1)

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; Other: In hospital questionnaires; Other: Telephone contact at 3 months

Interventions

In hospital pain evaluation OTHER

Patients will evaluate their pain levels via a verbal numerical scale on days 1(or-1), 2, 3, 4, 5, 6 \& 7.

The study population

In hospital questionnaires OTHER

Patients are required to fill out the PCS questionnaire between on day -1 or +1.

The study population

Telephone contact at 3 months OTHER

Patients will be contacted at 3 months post-surgery for pain questionnaires DN4 and EQ5D5L.

The study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 15733628 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joël L'Hermite, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joël L'Hermite, MD

CONTACT

+33.(0)4.66.68.36.18; joel.lhermite@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 14, 2022
• Study Start: February 23, 2021
• Primary Completion: February 23, 2024
• Study Completion: May 23, 2024
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

FR (1)