Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery (HYPNOMAIN)

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.

Study Overview

• Status: Recruiting
• Conditions: Hand Surgery
• Intervention / Treatment: Drug: Neuroleptanalgesic treatment; Other: Hypnoanalgesia

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

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mélanie FROMENTIN, MD; Phone Number: 33 01 86 86 66 00; Email: mfromentin.anesthesierea@gmail.com

Study Locations

• France
  • Champigny-sur-Marne, France, 94500
    • Recruiting
    • Hôpital Privé Paul d'Egine
    • Contact: Mélanie FROMENTIN, MD; Phone Number: 33 01 86 86 66 00; Email: mfromentin.anesthesierea@gmail.com
    • Principal Investigator: Mélanie FROMENTIN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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)	Drug: Neuroleptanalgesic treatment; Usual neuroleptanalgesic treatment Hypnovel and Locoregional anesthesia; Other Names: Hypnovel
Experimental: 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.	Other: Hypnoanalgesia; Hypnoanalgesia and Locoregional anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity assessment	Pain intensity will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable).	Day 0
Pain intensity assessment	Pain intensity will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable).	Day 2
Overall patient satisfaction	Overall patient satisfaction will be assessed using a simple numerical scale (ENS) graduated from 0 (not at all satisfied) to 10 (completely satisfied).	Day 0
Overall patient satisfaction	Overall patient satisfaction will be assessed using a simple numerical scale (ENS) graduated from 0 (not at all satisfied) to 10 (completely satisfied).	Day 2
Treatment Safety	The safety will be assessed by collecting data on adverse events occurring during the study.	Day 2

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Vivactis M2Research
• Investigators: Principal Investigator: Mélanie FROMENTIN, MD, Hôpital Privé Paul d'Egine

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2023-A00880-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No