Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neuroleptanalgesic treatment, Hypnoanalgesia.
- Who it may be relevant to
- Registry conditions: Hand Surgery. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
In a population of patients undergoing hand surgery and divided into two groups according to the anesthesia protocol administered in addition to locoregional anesthesia by truncal block:
Group 1: neuroleptanalgesia Group 2: hypnoanalgesia Primary objective The main objective of the study is to compare changes in preoperative anxiety between the two groups, between two measurements taken preoperatively (before anxiety management) and at the end of surgery. This level will be evaluated using a VAS rated from 0 to 10.
Secondary objectives
Comparing groups:
* Intraoperative pain * Total duration of surgical procedure, ICU stay and hospitalization * Amount of additional sedative treatment administered during surgery * Post-operative pain * Patient satisfaction * Intraoperative and immediate postoperative adverse events
Interventions
- Drug Neuroleptanalgesic treatment
Usual neuroleptanalgesic treatment Hypnovel and Locoregional anesthesia - Other Hypnoanalgesia
Hypnoanalgesia and Locoregional anesthesia
Primary outcome measures
- VAS anxiety score [Time frame: Day 2]
Secondary outcome measures (5)
- Pain intensity assessment [Time frame: Day 0]
- Pain intensity assessment [Time frame: Day 2]
- Overall patient satisfaction [Time frame: Day 0]
- Overall patient satisfaction [Time frame: Day 2]
- Treatment Safety [Time frame: Day 2]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Hôpital Privé Paul d'Egine — Champigny-sur-Marne
Identifiers
NCT: NCT06185829 · 2023-A00880-45