NCT06185829

Evaluating the Benefit of Hypnoanalgesia Versus Neuroleptanalgesia During Hand Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Neuroleptanalgesic treatment	Usual neuroleptanalgesic treatment Hypnovel and Locoregional anesthesia
OTHER	Hypnoanalgesia	Hypnoanalgesia and Locoregional anesthesia

Timeline

• Start date: 2023-10-19
• Primary completion: 2026-11-01
• Completion: 2027-01-01
• First posted: 2023-12-29
• Last updated: 2025-12-09

Locations

1 site across 1 country: France