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Clinical Trial 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.


Clinical Trial 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 Design


NCT number NCT06185829
Study type Interventional
Source GCS Ramsay Santé pour l'Enseignement et la Recherche
Contact Mélanie FROMENTIN, MD
Phone 01 86 86 66 00
Email mfromentin.anesthesierea@gmail.com
Status Recruiting
Phase N/A
Start date October 19, 2023
Completion date November 2, 2024