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

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Hand Surgery

Treatments: Drug: Neuroleptanalgesic treatment; Other: Hypnoanalgesia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06185829

2023-A00880-45

Details and patient eligibility

About

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.

Full 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

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Usual neuroleptanalgesic treatment

Active Comparator group

Description:

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)

Treatment:

Drug: Neuroleptanalgesic treatment

Hypnoanalgesia

Experimental group

Description:

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.

Treatment:

Other: Hypnoanalgesia