Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery

2023-A00880-45

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.

2023-10-19

2024-11-02

2024-11-02

Recruiting

64

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, prospective, randomized, open label study with two parallel groups of patients.\n\nMaximum duration of patient participation = 3 days.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 64, 'type': 'ESTIMATED'}}

2023-12-29