💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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 Criteria:
* 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.
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