Preoperative TAP Block Versus Postoperative TAP Block in Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Controlled Trial
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: Preoperative TAP Block, Postoperative TAP block.
- Кому может быть актуально
- Состояния в реестре: TAP Block. Базовые параметры: от 18 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
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The goal of this clinical trial is to learn if the regional anesthesia technique "TAP block" provide more analgesia when performed before or after the surgery. The main questions it aims to answer are: Does preoperative TAP block provide greater analgesia than postoperative TAP block? Patients receiving preoperative TAP block will have less pain and take less painkillers than patients receiving postoperative TAP block? Participants will: Receive preoperative or postoperative TAP block They will be asked about their pain levels during the hospital stay.
Подробное описание
The TAP block is a safe, easy-to-perform, and effective technique for managing postoperative pain. It reduces opioid consumption and increases patient satisfaction. Despite recent studies indicating that postoperative TAP block might be more effective than preoperative TAP block in reducing opioid use within 24 hours, the optimal timing of its administration (before or after surgery) remains unclear.
In this study we will compare preoperative to postoperative TAP block in patients undergoing laparoscopic cholecistectomy.
The primary aim of this study is to determine the difference in postoperative pain control between preoperative and postoperative TAP block administration in patients undergoing laparoscopic cholecystectomy.
The primary objective will be to evaluate the difference in postoperative pain at rest, 24 hours after surgery, between patients receiving preoperative versus postoperative TAP block. Pain will be assessed using the Numeric Rating Scale (NRS) from 0 to 10.
Secondary objectives will be intraoperative and postoperative opioids, postoperative nausea and vomiting, pain at resnt and on movement at 0,6,12,24 hours.
Вмешательства
- Процедура Preoperative TAP Block
Patients will receive preoperative TAP block - Процедура Postoperative TAP block
Patients will receive postoperative TAP block
Первичные конечные точки
- Patient reported pain on movement at 24 hours after the surgery [Срок оценки: At the 24th hour after the end of the surgery.]
Вторичные конечные точки (10)
- Patient reported pain on movement (cough) at the end of the surgery [Срок оценки: At the end of the surgery.]
- Patient reported pain on rest at the end of the surgery [Срок оценки: At the end of the surgery.]
- Patient reported pain on rest at 6 hours after the surgery [Срок оценки: At the 6th hour after the end of the surgery.]
- Patient reported pain on movement at 6 hours after the surgery [Срок оценки: At the 6th hour after the end of the surgery.]
- Patient reported pain on rest at 12 hours after the surgery [Срок оценки: At the 12th hour after the end of the surgery.]
- Patient reported pain on movement at 12 hours after the surgery [Срок оценки: At the 12th hour after the end of the surgery.]
- Patient reported pain on rest at 24 hours after the surgery [Срок оценки: At the 24th hour after the end of the surgery.]
- Difference in intraoperative opioids [Срок оценки: From the enrollment to the extubation]
- Difference in postoperative opioids [Срок оценки: From the extubation to the 24th postoperative hours]
- Number of participants experiencing postoperative nausea and vomiting [Срок оценки: From extubation to the 24th postoperative hour]
Критерии участия
Критерии включения
- ASA I-II patients
- Age >18 years
- Informed consent
Критерии исключения
- History of chronic pain
- Beta-blocker therapy
- Allergy to the drugs used in the study
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
Италия · 1 центр
- University Hospital of Padua — Padua
Идентификаторы
NCT: NCT06903182 · 6126/AO/24