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In a population of patients undergoing hemorrhoidal surgery under general anesthesia and divided into two equal groups based on the method used for intraoperative pudendal nerve block and its branches in the ischioanal fossa: Group 1: Pudendal block guided by neurostimulation Group 2: Pudendal block guided by ultrasound The primary objective of this study is to compare the maximum immediate postoperative pain score between the two groups (pain reported by the patients in the recovery room on a simple numeric scale before morphine titration).
This is a multicenter, prospective, randomized, double-blind study conducted on two parallel groups of patients undergoing hemorrhoidal surgery (pudendal block guided by neurostimulation versus pudendal block guided by ultrasound). Study Duration The total study duration per patient is 7 days. The recruitment period is set at 12 months. Justification of the Experimental Protocol The aim of this study is to compare two methods of performing a pudendal block. Patient allocation to either strategy will be determined by randomization. Bilateral pudendal nerve block and its branches in the ischioanal fossa will be performed after induction of general anesthesia. To maintain double blinding, postoperative data will be collected by a physician other than the anesthesiologist performing the block, and by nursing staff under their supervision. None of these personnel will be informed of the patient's group allocation.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hôpital Privé Claude Galien
Quincy-sous-Sénart, France
Start Date
August 1, 2025
Primary Completion Date
August 8, 2026
Completion Date
August 8, 2026
Last Updated
June 11, 2025
202
ESTIMATED participants
Neurostimulation
PROCEDURE
Ultrasound
PROCEDURE
Lead Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06660680