Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery

NCT06185829 | Recruiting

• 1 other identifier: 2023-A00880-45
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hand Surgery

Outcome Measures

Primary Outcomes (1)

• VAS anxiety score

  Changes in VAS anxiety score between preoperative and intraoperative assessment. Anxiety will be assessed on a visual analog scale measuring 10 cm (with 0 = no stress - 10 = major stress) and by administering the APAIS scale.

  Day 2

Secondary Outcomes (5)

• Pain intensity assessment

  Day 0

• Pain intensity assessment

  Day 2

• Overall patient satisfaction

  Day 0

• Overall patient satisfaction

  Day 2

• Treatment Safety

  Day 2

Study Arms (2)

Usual neuroleptanalgesic treatment

ACTIVE COMPARATOR

Usual neuroleptanalgesic treatment Hypnovel (1 mg if weight \< 60 kg, 1.5 mg if weight between 60 and 80 kg, 2 mg if weight \> 80 kg)

Drug: Neuroleptanalgesic treatment

Hypnoanalgesia

EXPERIMENTAL

Patients in this group will begin their hypnoanalgesia session with a nurse trained in hypnotherapy. Various methods commonly used in hypnosis (VAKOG, dissociation, diversion, metaphors, etc.) will be selected based on the patient, their personality, their expectations, and their degree of suggestibility.

Other: Hypnoanalgesia

Interventions

Neuroleptanalgesic treatment DRUG

Usual neuroleptanalgesic treatment Hypnovel and Locoregional anesthesia

Also known as: Hypnovel

Usual neuroleptanalgesic treatment

Hypnoanalgesia OTHER

Hypnoanalgesia and Locoregional anesthesia

Hypnoanalgesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Vivactis M2Research: collaborator

Study Sites (1)

Hôpital Privé Paul d'Egine

Champigny-sur-Marne, 94500, France

RECRUITING

Study Officials

• Mélanie FROMENTIN, MD

  Hôpital Privé Paul d'Egine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mélanie FROMENTIN, MD

CONTACT

01 86 86 66 00; mfromentin.anesthesierea@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, randomized, open label study with two parallel groups of patients. Maximum duration of patient participation = 3 days.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: October 19, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)