Clinical trial NCT05326737: Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months
Official title: Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months: a Single-center Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Procedures, Operative
Pain
Chronic Pain
Keywords: pain trajectory
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 5000
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 ffor a predefined list of surgeries.

Brief summary: The effective management of acute postoperative pain remains a daily challenge despite the organizational efforts made and the techniques put in place.

Thirty percent of patients who undergo surgery suffer from chronic post-surgical pain, of which 5 to 10% are of severe intensity. Many preoperative, intraoperative, and postoperative factors, related to the patient, the surgical procedure, or the anesthetic technique, have been incriminated as risk factors for chronic post-surgical pain. The severity of acute postoperative pain is recognized as one of the risk factors for the occurrence of chronic post-surgical pain on which we can hope to interact during the peri-operative period.

In this cohort study, we wish to define the typologies of postoperative pain trajectories observed from Day 0 to Day 7 and to estimate the proportion of patients with an abnormal resolution of pain in a model of organization such as that of our institution, in classic hospitalization and in ambulatory care.


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

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
Secondary outcomes:
measure: The DN4 questionnaire
timeFrame: month 3
measure: The EuroQuol EQ5D5L questionnaire
timeFrame: month 3
measure: Since the surgery, do you have persistent pain? yes/no
timeFrame: month 3
measure: Verbal numerical 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: 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.