- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04546594
Epidemiological Data on Pain (ALGOBASES)
December 17, 2025 updated by: University Hospital, Lille
Collection of Epidemiological Data on Pain Related to Orthopedic, Thoracic or Gynecological Surgery
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.
Study Overview
Status
Withdrawn
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Adult patients consulting at the university hospital of Lille and needing orthopedic, thoracic, gynecological surgical management with or without painful symptoms and chronic painful patients in the context of organ pathologies.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Orthopedic surgery
|
|
Thoracic surgery
|
|
Gynecological surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Descriptive analysis of specific symptomatology of pain Description of the general and painful symptomatology in patients needing surgery.
Time Frame: follow-up over a period of five years during post-operative or pain medical consultation
|
Describe the specific symptomatology of pain separately according to the 3 pathologies: patients needing orthopedic, thoracic and gynecological surgery.
|
follow-up over a period of five years during post-operative or pain medical consultation
|
|
Pain Catastrophizing Scale (PCS) according to pain
Time Frame: Baseline and follow-up over a period of five years during post-operative or pain medical consultation
|
Baseline and follow-up over a period of five years during post-operative or pain medical consultation
|
|
|
Hospital Anxiety Depression scale (HAD) according to pain
Time Frame: Baseline and follow-up over a period of five years during post-operative or pain medical consultation
|
Baseline and follow-up over a period of five years during post-operative or pain medical consultation
|
|
|
EQD5 according to pain
Time Frame: Baseline and follow-up over a period of five years during post-operative or pain medical consultation
|
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.
Time Frame: Baseline and at three months, six months, one year
|
The presence of pain will be defined by the presence of severe pain and/or the presence of neuropathic pain.
|
Baseline and at three months, six months, one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jean-Michel Wattier, MD, University Hospital, Lille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2020
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
September 4, 2020
First Submitted That Met QC Criteria
September 4, 2020
First Posted (Actual)
September 14, 2020
Study Record Updates
Last Update Posted (Estimated)
December 23, 2025
Last Update Submitted That Met QC Criteria
December 17, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNI_2018_76
- 2020-A01112-37 (Other Identifier: ID-RCB number,ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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