Clinical trial NCT02599233: Characterization of Post-operative Pain Trajectories Over Seven Days and Links With Chronicity
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedures, Operative
Pain
Chronic Pain
Keywords: pain trajectory
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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

Primary outcomes:
measure: The pain trajectory for the first 7 post-operative days.
timeFrame: Day 7 post-surgery
Secondary outcomes:
measure: The DN4 questionnaire
timeFrame: month 3
measure: Since the surgery, do you have persistent pain? yes/no
timeFrame: month 3
measure: Is it the same pain before the surgery? yes/no
timeFrame: month 3
measure: Verbal numberical scale for pain (ranging from 0 to 10)
timeFrame: month 3
measure: Have you had complications from your surgery? yes/no
timeFrame: month 3
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: day -1 or day +1
measure: Pain Catastrophizing Scale (PCS)
timeFrame: day -1 or day +1
measure: Cumulative consumption of antalgic drugs
timeFrame: day -1 or day +1
measure: Cumulative consumption of antalgic drugs
timeFrame: day 2
measure: Cumulative consumption of antalgic drugs
timeFrame: day 3
measure: Cumulative consumption of antalgic drugs
timeFrame: day 4
measure: Cumulative consumption of antalgic drugs
timeFrame: day 5
measure: Cumulative consumption of antalgic drugs
timeFrame: day 6
measure: Cumulative consumption of antalgic drugs
timeFrame: day 7
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Joël L'Hermite, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sullivan, M. J., Bishop, S. R., & Pivik, J. The pain catastrophizing scale: development and validation. Psychological assessment, 1995, 7(4), 524.
citation: 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.