Hôpital Privé Paul d'Egine
Champigny-sur-Marne, 94500, France
Location status: Recruiting
NCT Number: NCT06185829
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Champigny-sur-Marne, 94500, France
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Usual neuroleptanalgesic treatment Hypnovel and Locoregional anesthesia
Other names: Hypnovel
Hypnoanalgesia and Locoregional anesthesia
Time frame: Day 2
Changes in VAS anxiety score between preoperative and intraoperative assessment.
Anxiety will be assessed on a visual analog scale measuring 10 cm (with 0 = no stress - 10 = major stress) and by administering the APAIS scale.
Time frame: Day 0
Pain intensity will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Day 2
Pain intensity will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable).
Time frame: Day 0
Overall patient satisfaction will be assessed using a simple numerical scale (ENS) graduated from 0 (not at all satisfied) to 10 (completely satisfied).
Time frame: Day 2
Overall patient satisfaction will be assessed using a simple numerical scale (ENS) graduated from 0 (not at all satisfied) to 10 (completely satisfied).
Time frame: Day 2
The safety will be assessed by collecting data on adverse events occurring during the study.
Contact information is provided by the study sponsor or research team.
GCS Ramsay Santé pour l'Enseignement et la Recherche
Other
Acronym: HYPNOMAIN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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