PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Pudendal block AL, Sacral ESP block AL, Sacral ESP block Sham, Pudendal block Sham.
- Кому может быть актуально
- Состояния в реестре: Hemorrhoids, Hemorrhoids Third Degree. Базовые параметры: 18 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Швейцария
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Randomized, Double-Blind Trial Comparing Pudendal Block Versus Sacral ESP for Ambulatory Hemorrhoidectomy
Обзор
The goal of this clinical trial is to learn if the sacral erector spinae plane block can provide equal or better pain control than the pudendal nerve block in adults undergoing hemorrhoid surgery. The main question is: Which block offers more effective analgesia and faster recovery?
Подробное описание
Hemorrhoidectomy remains one of the most common anorectal procedures performed worldwide, yet it is frequently associated with significant postoperative pain that can impair recovery, delay discharge, and increase unplanned healthcare utilization. Effective analgesia is therefore a central component of perioperative care in this population.
Traditionally, the pudendal nerve block has been used to provide postoperative analgesia after hemorrhoidectomy. While effective, this technique requires precise anatomical identification, can be technically challenging, and is associated with potential risks such as vascular puncture or local anesthetic systemic toxicity. More recently, the sacral erector spinae plane (ESP) block has been described as a simpler, ultrasound-guided technique that may provide effective analgesia for procedures involving the perineal and anorectal region. Its safety profile and ease of performance could represent an attractive alternative to the pudendal nerve block, especially in the ambulatory setting.
The PUSHES trial is designed as a randomized, controlled, double-blind study to directly compare the efficacy of sacral ESP block versus pudendal nerve block for pain control after ambulatory hemorrhoidectomy. A total of 64 adult patients undergoing elective hemorrhoidectomy under standardized spinal anesthesia will be enrolled. Following spinal anesthesia, participants will be randomized to receive either a sacral ESP block with ropivacaine and a sham pudendal block with saline, or a pudendal block with ropivacaine and a sham sacral ESP block with saline. This double-dummy design ensures blinding of patients, anesthesiologists, and outcome assessors.
The primary endpoint is pain intensity at 4 hours postoperatively, measured using a 10-point Visual Analog Scale (VAS). Secondary endpoints include pain scores at 12 and 24 hours, time to first rescue analgesia, opioid consumption, functional recovery milestones (mobilization, ability to void, return to baseline activity), and block-related or systemic adverse events.
By systematically comparing these two techniques, this trial aims to identify whether the sacral ESP block can provide equivalent or superior analgesia to the pudendal nerve block while offering a simpler, safer alternative for routine clinical practice.
Вмешательства
- Процедура Pudendal block AL
Patients in the control group will receive an ultrasound-guided bilateral pudendal nerve block with 20 mL of 0.75% ropivacaine - Процедура Sacral ESP block AL
Patients in the intervention group will receive an ultrasound-guided sacral ESP block with 20 mL of 0.75% ropivacaine - Процедура Sacral ESP block Sham
Patients in the control group will receive a sacral ESP block with 20 mL of normal saline. - Процедура Pudendal block Sham
Patients will receive a bilateral pudendal nerve block with 20 mL of normal saline.
Первичные конечные точки
- Postoperative pain intensity, assessed using the Visual Analogue Scale (VAS) at 4 hours following surgery in day 0 [Срок оценки: Day 0]
Вторичные конечные точки (3)
- VAS (Visual Analogue Score) pain scores at 12 hours and 24 hours postoperatively [Срок оценки: Day 0 and day 1]
- Time to first request for rescue analgesia in 24 hours [Срок оценки: Day 0 and day 1]
- Total amount of rescue analgesia in 24 hours [Срок оценки: Day 0 and day 1]
Критерии участия
Критерии включения
- Adults (≥18 years old) scheduled for elective excisional hemorrhoidectomy;
- Ability to understand the nature of the study and provide written informed consent;
- American Society of Anesthesiologists (ASA) physical status I-III;
- Ability to comply with study procedures and postoperative evaluations.
Критерии исключения
- Pregnancy;
- Body weight under 50 kg due to the potential risk of local anaesthetic systemic toxicity (LAST);
- BMI > 40; Known allergy or contraindication to local anaesthetics (e.g., ropivacaine, prilocaine);
- Severe coagulation disorders or current anticoagulant therapy contraindicating spinal or peripheral deep nerve blocks (like pudendal block, because Sacral ESP is considered a superficial block);
- Infection at the puncture site;
- Neurological disorders affecting the sacral or pudendal nerve pathways;
- Severe psychiatric conditions impairing study participation;
- Language barriers
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
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Швейцария · 1 центр
- Ospedale Regionale Bellinzona e Valli (ORBV) CH-6500 Bellinzona Switzerland — Bellinzona
Публикации
- Kaya C, Dost B, Tulgar S. Sacral Erector Spinae Plane Block Provides Surgical Anesthesia in Ambulatory Anorectal Surgery: Two Case Reports. Cureus. 2021 Jan 9;13(1):e12598. doi: 10.7759/cureus.12598. PMID 33585088
Идентификаторы
NCT: NCT07350460 · PUSHES trial