Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery

NCT ID: NCT06185829

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-19
• Study Completion Date: 2027-01-31

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.

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

Conditions

Hand Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Hypnoanalgesia

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.

Group Type: EXPERIMENTAL

Hypnoanalgesia

Intervention Type: OTHER

Hypnoanalgesia and Locoregional anesthesia

Usual neuroleptanalgesic treatment

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)

Group Type: ACTIVE_COMPARATOR

Neuroleptanalgesic treatment

Intervention Type: DRUG

Usual neuroleptanalgesic treatment Hypnovel and Locoregional anesthesia

Interventions

Neuroleptanalgesic treatment

Usual neuroleptanalgesic treatment Hypnovel and Locoregional anesthesia

Intervention Type: DRUG

Hypnoanalgesia

Hypnoanalgesia and Locoregional anesthesia

Intervention Type: OTHER

Other Intervention Names

Hypnovel

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vivactis M2Research

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mélanie FROMENTIN, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Privé Paul d'Egine

Locations

Hôpital Privé Paul d'Egine

Champigny-sur-Marne, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Mélanie FROMENTIN, MD

Role: CONTACT

mfromentin.anesthesierea@gmail.com

01 86 86 66 00 ext. 33

Facility Contacts

Mélanie FROMENTIN, MD

Role: primary

mfromentin.anesthesierea@gmail.com

01 86 86 66 00 ext. 33

Other Identifiers

2023-A00880-45

Identifier Type: -

Identifier Source: org_study_id