Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery

Last updated: June 28, 2024
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Overall Status: Active - Recruiting

Phase

N/A

Condition

Orthopedics

Treatment

Neurloeptanalgesic treatment

Hypnoanalgesia

Clinical Study ID

NCT06185829
2023-A00880-45
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged between 18 and 80,

  • Patient who has read and signed the consent form for participation in the studyafter a reflection period (approximately 15 minutes).

  • Patient applying for outpatient hand surgery under LRA, such as upper limb trunkblocks (flexor teno synovectomy or endoscopic carpal tunnel surgery).

  • Patient requiring sedation associated with locoregional anaesthesia

Exclusion

Exclusion Criteria:

  • Contraindication to locoregional anaesthesia or to one of the sedatives used in theprotocol

  • Pregnant or breastfeeding patient or woman of childbearing age without highlyeffective contraception for the duration of the study (surgically sterile,intrauterine device (> 14 days), hormonal contraception (same dose and formulationfor 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. Apost-menopausal state is defined as the absence of menstruation for 12 monthswithout 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 informedconsent: dementia, psychosis, disturbed consciousness, non-French-speaking patients,etc.

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Neurloeptanalgesic treatment
Phase:
Study Start date:
October 19, 2023
Estimated Completion Date:
November 02, 2024

Study 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

Connect with a study center

  • Hôpital Privé Paul d'Egine

    Champigny-sur-Marne, 94500
    France

    Active - Recruiting

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