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

NCT ID: NCT05326737

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2024-05-23

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

In hospital pain evaluation

Intervention Type: OTHER

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

In hospital questionnaires

Intervention Type: OTHER

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

Telephone contact at 3 months

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

In hospital questionnaires

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

Intervention Type: OTHER

Telephone contact at 3 months

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joël L'Hermite, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Joël L'Hermite, MD

Role: CONTACT

joel.lhermite@chu-nimes.fr

+33.(0)4.66.68.36.18

References

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.

Reference Type: BACKGROUND

PMID: 15733628 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

2020-A03223-36

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2020/PC-02

Identifier Type: -

Identifier Source: org_study_id