Status:
RECRUITING
Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery
Lead Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborating Sponsors:
Vivactis M2Research
Conditions:
Hand Surgery
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a single-center, prospective, randomized, open-label study of two parallel groups of patients undergoing hand surgery: Group 1: locoregional anesthesia + neuroleptanalgesia Group 2: locoregio...
Detailed Description
In a population of patients undergoing hand surgery and divided into two groups according to the anesthesia protocol administered in addition to locoregional anesthesia by truncal block: Group 1: neu...
Eligibility Criteria
Inclusion
- Patients aged between 18 and 80,
- Patient who has read and signed the consent form for participation in the study after a reflection period (approximately 15 minutes).
- Patient applying for outpatient hand surgery under LRA, such as upper limb trunk blocks (flexor teno synovectomy or endoscopic carpal tunnel surgery).
- Patient requiring sedation associated with locoregional anaesthesia
Exclusion
- Contraindication to locoregional anaesthesia or to one of the sedatives used in the protocol
- Pregnant or breastfeeding patient or woman of childbearing age without highly effective contraception for the duration of the study (surgically sterile, intrauterine device (\> 14 days), hormonal contraception (same dose and formulation for at least 6 months), sexual abstinence. Women of childbearing age, i.e. fertile, are considered to be women after menarche and until they become post-menopausal, unless they are permanently infertile or have undergone surgical sterilisation. A post-menopausal state is defined as the absence of menstruation for 12 months without any other medical cause.
- Patient under court protection, guardianship or curatorship
- Patient not affiliated to the French social security system
- Patients unable to understand informed information and/or give written informed consent: dementia, psychosis, disturbed consciousness, non-French-speaking patients, etc.
Key Trial Info
Start Date :
October 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06185829
Start Date
October 19 2023
End Date
January 1 2027
Last Update
December 9 2025
Active Locations (1)
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1
Hôpital Privé Paul d'Egine
Champigny-sur-Marne, France, 94500