Epidemiological Data on Pain

Pain Clinical Trial

— ALGOBASES  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Dystocia
• Gynecological; Surgery (Previous), Causing Obstructed Labor, Affecting Fetus
• Musculoskeletal Diseases
• Orthopedic Disorder
• Pain
• Thoracic

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