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Clinical Trials/NCT05326737
NCT05326737
Unknown
Not Applicable

Evaluation of Pain Trajectories After Surgery and Their Potential Relationship With Chronicity at 3 Months: a Single-center Prospective Cohort Study

Centre Hospitalier Universitaire de Nīmes1 site in 1 country5,000 target enrollmentFebruary 23, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgical Procedures, Operative
Sponsor
Centre Hospitalier Universitaire de Nīmes
Enrollment
5000
Locations
1
Primary Endpoint
The pain trajectory for the first 7 post-operative days.
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 23, 2021
End Date
May 23, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

The pain trajectory for the first 7 post-operative days.

Time Frame: Day 7

The pain trajectory is the change in pain level evaluated by verbal numerical pain (from 0 to 10) from day 0 (surgery) to day 7.

Secondary Outcomes

  • The EuroQuol EQ5D5L questionnaire(month 3)
  • Have you had complications from your surgery? yes/no(month 3)
  • Cumulative consumption of antalgic drugs(day 7)
  • The DN4 questionnaire(month 3)
  • Pain Catastrophizing Scale (PCS)(day -1 or day +1)
  • Since the surgery, do you have persistent pain? yes/no(month 3)
  • Verbal numerical scale for pain (ranging from 0 to 10)(month 3)

Study Sites (1)

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