Characterization of Post-operative Pain Trajectories Over Seven Days and Links With Chronicity

NCT ID: NCT02599233

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 392 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2016-11-03

Brief Summary

The main objective of this study is to establish the postoperative "pain pathways" observed from D1 to D7 in the context of the current management after orthopedic, digestive, obstetrics and gynecology, urology, neurosurgery, vascular and thoracicn surgeries.

Detailed Description

The secondary objectives of this study are:

A. To assess the incidence of Post-Surgical Chronic Pain (PSCP) Chronic 3 months post intervention.

B. To asses the incidence of neuropathic type pain (DN4 Questionnaire) at 3 months post intervention.

C. To study the potential links between pain trajectories and the presence or absence of PSCP.

D. To study the potential links between the presence or absence of PSCP and known risk factors for PSCP (patient-related data, data on the surgery, anesthesia data).

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 for a predefined six month period and for a predefined list of surgeries. The latter list of surgical acts was established according to the Medicalization of Information Systems Progam (PMSI) database. Patients are recruited either the day before or the day after surgery, in their respective departments.

Interventions:

• In hospital pain evaluation
• In hospital questionnaires
• Telephone conctact at 3 months

Telephone conctact at 3 months

Intervention Type: OTHER

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

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 HADS and PCS questionnaires between on day -1 or +1.

Interventions

Telephone conctact at 3 months

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

Intervention Type: 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.

Intervention Type: OTHER

In hospital questionnaires

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

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 (HADS, PCS, EN, DN4)

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

Countries

France

References

L'Hermite J, Page MG, Chevallier T, Occean B, Viel E, Bredeau O, Lefrant JY, Cuvillon P. Characterisation of pragmatic postoperative PAin Trajectories over seven days and their association with CHronicity after 3 months: a prospective, pilot cohort study (PATCH study). Anaesth Crit Care Pain Med. 2021 Feb;40(1):100793. doi: 10.1016/j.accpm.2020.100793. Epub 2020 Dec 23.

Reference Type: RESULT

PMID: 33359373 (View on PubMed)

Other Identifiers

2015-A00868-41

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2015/JLH-01

Identifier Type: -

Identifier Source: org_study_id