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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04546594
Other study ID # RNI_2018_76
Secondary ID 2020-A01112-37
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2020
Est. completion date September 2025

Study information

Verified date September 2020
Source University Hospital, Lille
Contact Jean-Michel Wattier, MD
Phone 0320445962
Email jean-michel.wattier@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 17 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Outcome

Type Measure Description Time frame Safety issue
Primary Descriptive analysis of the typology of pain in patients needing surgery. 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 Descriptive analysis of specific symptomatology of pain Description of the general and painful symptomatology in patients needing surgery. 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
Secondary Pain Catastrophizing Scale (PCS) according to pain Baseline and follow-up over a period of five years during post-operative or pain medical consultation
Secondary 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
Secondary EQD5 according to pain Baseline and follow-up over a period of five years during post-operative or pain medical consultation
Secondary Identification of factors predictive of acute or chronic pain. 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
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