Comparing hypnoanalgesia and neuroleptanalgesia for hand surgery
Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery
This study is testing whether a new way of calming patients with hypnosis works better than traditional sedation during hand surgery to see which one helps reduce anxiety and pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Champigny-sur-Marne) |
| Trial ID | NCT06185829 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two different sedation methods, hypnoanalgesia and neuroleptanalgesia, in patients undergoing hand surgery. Participants are randomly assigned to one of the two groups, both receiving locoregional anesthesia. The primary focus is on measuring changes in preoperative anxiety using a Visual Analog Scale (VAS) before and after surgery. Secondary objectives include assessing intraoperative pain, duration of surgery, patient satisfaction, and any adverse events.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 requiring outpatient hand surgery with locoregional anesthesia.
Not a fit: Patients with contraindications to locoregional anesthesia or the sedatives used in the study will not benefit.
Why it matters
Potential benefit: If successful, this study could lead to improved anxiety management and pain control during hand surgeries.
How similar studies have performed: Previous studies have shown promising results with hypnoanalgesia in various surgical settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Champigny-sur-Marne
- Hôpital Privé Paul d'Egine — Champigny-sur-Marne, France (Recruiting)
Study contacts
- Principal investigator: Mélanie FROMENTIN, MD — Hôpital Privé Paul d'Egine
- Study coordinator: Mélanie FROMENTIN, MD
- Email: mfromentin.anesthesierea@gmail.com
- Phone: 01 86 86 66 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.