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

NCT02599233 | Completed

• 2 other identifiers: LOCAL/2015/JLH-012015-A00868-41
• Study Type: observational
• Target: 392
• Locations: 1 country
• Sites: 1

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.

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 vector of 7 verbal numerical pain estimates (from 0 to 10) taken over 7 days (days 1 (or -1), 2, 3, 4, 5, 6 \& 7). Day 0 is the day of surgery.

  Day 7 post-surgery

Secondary Outcomes (14)

• The DN4 questionnaire

  month 3

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

  month 3

• Is it the same pain before the surgery? yes/no

  month 3

• Verbal numberical 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 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

Other: Telephone conctact at 3 months; Other: In hospital pain evaluation; Other: In hospital questionnaires

Interventions

Telephone conctact at 3 months OTHER

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

The study population

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

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 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.

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 (HADS, PCS, EN, DN4)

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

Location

Related Publications (1)

• 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.

  PMID: 33359373 RESULT

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

Study Design

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

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 6, 2015
• Study Start: March 1, 2016
• Primary Completion: November 3, 2016
• Study Completion: November 3, 2016
• Last Updated: November 19, 2025

Record last verified: 2017-01

Locations

FR (1)