RecruitingNot ApplicableNCT06185829
Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Enrollment
64 participants
Start Date
Oct 19, 2023
Study Type
INTERVENTIONAL
Conditions
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: locoregional anesthesia + hypnoanalgesia Therapeutic benefit is based on VAS assessment of intraoperative anxiety.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria4
- 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 Criteria5
- 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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Interventions
DRUGNeuroleptanalgesic treatment
Usual neuroleptanalgesic treatment Hypnovel and Locoregional anesthesia
OTHERHypnoanalgesia
Hypnoanalgesia and Locoregional anesthesia
Locations(1)
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NCT06185829