Clinical trial NCT06185829: Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery
Official title: Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Surgery
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Vivactis M2Research
First posted: 2023-12-29
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, prospective, randomized, open label study with two parallel groups of patients.

Maximum duration of patient participation = 3 days.
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: VAS anxiety score
timeFrame: Day 2
Secondary outcomes:
measure: Pain intensity assessment
timeFrame: Day 0
measure: Pain intensity assessment
timeFrame: Day 2
measure: Overall patient satisfaction
timeFrame: Day 0
measure: Overall patient satisfaction
timeFrame: Day 2
measure: Treatment Safety
timeFrame: Day 2
Other outcomes:
Locations:
city: Champigny-sur-Marne
country: France
facility: Hôpital Privé Paul d'Egine
Study officials:
affiliation: Hôpital Privé Paul d'Egine
name: Mélanie FROMENTIN, MD
role: PRINCIPAL_INVESTIGATOR
References: