Evaluation of the Analgesic Efficacy of an Ultrasound-guided Transperineal Pudendal Block in Outpatient Hemorrhoidal Surgery

Обзор

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).

Подробное описание

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.

Вмешательства

• Процедура Neurostimulation
  Procedure guided by neurostimulation
• Процедура Ultrasound
  Procedure guided by ultrasound

Первичные конечные точки

• Postoperative Pain assessment in the Post-Anesthesia Care Unit (PACU) [Срок оценки: Hour 2]

Вторичные конечные точки (12)

• Quantitative Opioid Consumption [Срок оценки: Hour 2]
• Qualitative Opioid Consumption [Срок оценки: Hour 2]
• Postoperative recovery assessment [Срок оценки: Day 1]
• Postoperative recovery assessment [Срок оценки: Day 3]
• Postoperative recovery assessment [Срок оценки: Day 7]
• Postoperative Pain assessment at rest [Срок оценки: Day 1]
• Postoperative Pain assessment at rest [Срок оценки: Day 3]
• Postoperative Pain assessment at rest [Срок оценки: Day 7]
• Postoperative Pain assessment during walking [Срок оценки: Day 1]
• Postoperative Pain assessment during walking [Срок оценки: Day 3]
• Postoperative Pain assessment during walking [Срок оценки: Day 7]
• Postoperative Pain assessment during First defecation [Срок оценки: Day 7]

Критерии участия

Критерии включения

• Adult male or female patient
• Patient who has signed informed consent to participate in the study
• Patient scheduled for outpatient hemorrhoidal surgery under general anesthesia

Критерии исключения

• History of hemorrhoidal surgery
• Allergy or contraindication to any of the medications used in the study
• Patient undergoing surgery under spinal anesthesia
• History of chronic pain requiring opioid use, unrelated to hemorrhoids
• Mental impairment or any other condition that could hinder understanding or strict adherence to the protocol
• Patient not affiliated with the French national health insurance system
• Patient under legal protection (e.g., guardianship, trusteeship, or court protection)
• Pregnant woman or woman at risk of being pregnant (i.e., of childbearing age without effective contraception and without an HCG test)
• Patient already enrolled in another therapeutic clinical trial or within the exclusion period of another clinical trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hôpital Privé Claude Galien — Quincy-sous-Sénart

Публикации

• Giral T, Maupain O, Elmaleh Y, Huynh D, Ciceron F, Yao K, Devidas P, El Metni A, Kutter J. Ultrasound-guided versus neurostimulation-guided bilateral transperineal pudendal nerve block for analgesia in outpatient haemorrhoid surgery: protocol for a multicentre, randomised, double-blind, non-inferiority trial. BJA Open. 2025 Dec 9;16:100512. doi: 10.1016/j.bjao.2025.100512. eCollection 2025 Dec. PMID 41476689

Идентификаторы

NCT: NCT07015775 · 2025-A00534-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗