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

Characterization of Post-operative Pain Trajectories Over Seven Days and Their Potential Links With Chronicity After 3 Months: a Single-center, Prospective, Pilot Cohort Study at the Nîmes University Hospital

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.

Study Overview

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

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).

• Study Type: Observational
• Enrollment (Actual): 392

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

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 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.

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 (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

Study Plan

How is the study designed?

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 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: 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: Telephone conctact at 3 months; Patients will be contacted at 3 months post-surgery for pain questionnaires.; Other: In hospital questionnaires; Patients are required to fill out the HADS and PCS questionnaires between on day -1 or +1.

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 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 Outcome Measures

Outcome Measure	Time Frame
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
Hospital Anxiety and Depression Scale (HADS)	day -1 or day +1
Pain Catastrophizing Scale (PCS)	day -1 or day +1
Cumulative consumption of antalgic drugs	day -1 or day +1
Cumulative consumption of antalgic drugs	day 2
Cumulative consumption of antalgic drugs	day 3
Cumulative consumption of antalgic drugs	day 4
Cumulative consumption of antalgic drugs	day 5
Cumulative consumption of antalgic drugs	day 6
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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 5, 2015
• First Posted (Estimate): November 6, 2015

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: pain trajectory
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: LOCAL/2015/JLH-01; 2015-A00868-41 (Other Identifier: RCB number)