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

Completed

• Conditions: Surgical Procedures, Operative; Chronic Pain; Pain
• Interventions: Other: Telephone conctact at 3 months; Other: In hospital pain evaluation; Other: In hospital questionnaires

• Registration Number: NCT02599233
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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).

Study Timeline

• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-05
• Study First Posted: 2015-11-06
• Study Start: 2016-03
• Primary Completion: 2016-07
• Study Completion: 2016-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The study population	In hospital questionnaires	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
The study population	Telephone conctact at 3 months	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
The study population	In hospital pain evaluation	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

Primary Outcome Measures

Name	Time	Method
The pain trajectory for the first 7 post-operative days.	Day 7 post-surgery	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.

Secondary Outcome Measures

Name	Time	Method
The DN4 questionnaire	month 3
Since the surgery, do you have persistent pain? yes/no	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 7
Is it the same pain before the surgery? yes/no	month 3
Verbal numberical scale for pain (ranging from 0 to 10)	month 3

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France