Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery
Recruiting now · Not applicable
Conditions studied: Hand Surgery
In brief
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: locoregional anesthesia + hypnoanalgesia Therapeutic benefit is based on VAS assessment of intraoperative anxiety.
Key facts
- Study ID
- NCT06185829
- Run by
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- People needed
- 64
- Starts
- 2023-10-19
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2025-12-09
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Hôpital Privé Paul d'Egine — Champigny-sur-Marne, France (enrolling)
Full record on ClinicalTrials.gov
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