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Clinical Trials/NCT04546594
NCT04546594
Withdrawn
Not Applicable

Collection of Epidemiological Data on Pain Related to Orthopedic, Thoracic or Gynecological Surgery

University Hospital, Lille0 sites500 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Orthopedic Disorder
Sponsor
University Hospital, Lille
Enrollment
500
Primary Endpoint
Descriptive analysis of the typology of pain in patients needing surgery.
Status
Withdrawn
Last Updated
4 months ago

Overview

Brief Summary

The ALGOBASES project is an observational epidemiological study of pain through the collection of pain evaluation questionnaires and information with the aim of creating a descriptive "pain" evaluation in all patients who need to benefit from orthopedic, thoracic or gynecological surgery. The painful symptomatology will thus be evaluated in all its dimensions (demographic data, physical, psychological, socio-cultural components) and linked to the pathology justifying the specialized care. It is planned to collect the same data at each subsequent event in order to allow the determination of predictive factors, pain trajectories according to the type of surgery, and the profile of subjects at risk of acute or chronic postoperative pain.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
December 1, 2025
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient over 17 years old Patient needing orthopedic surgery Patient needing gynecological surgery Patient needing thoracic surgery Patient who has given written consent to participate in the trial. Socially insured patient Patient willing to comply with all study procedures and study duration

Exclusion Criteria

  • Age under 18 years old
  • Non-communicating patient
  • Patient does not understand French
  • Patient without social protection
  • Patient refusing to participate

Outcomes

Primary Outcomes

Descriptive analysis of the typology of pain in patients needing surgery.

Time Frame: Baseline

The typology of pain will be analyzed on the basis of responses to questionnaires on the affective and sensory dimension of pain, quality of life, depression, anxiety and catastrophizing

Secondary Outcomes

  • Hospital Anxiety Depression scale (HAD) according to pain(Baseline and follow-up over a period of five years during post-operative or pain medical consultation)
  • EQD5 according to pain(Baseline and follow-up over a period of five years during post-operative or pain medical consultation)
  • Identification of factors predictive of acute or chronic pain.(Baseline and at three months, six months, one year)
  • Descriptive analysis of specific symptomatology of pain Description of the general and painful symptomatology in patients needing surgery.(follow-up over a period of five years during post-operative or pain medical consultation)
  • Pain Catastrophizing Scale (PCS) according to pain(Baseline and follow-up over a period of five years during post-operative or pain medical consultation)

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