About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Neuroleptanalgesic treatment
- Hypnoanalgesia
Treatment groups
Sponsors and collaborators
GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead sponsor
Vivactis M2Research
Collaborator