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Идёт набор NCT07440940

Timing of Subcostal TAPB Combined With Rectus Sheath Block for Postoperative Pain After Laparoscopic Cholecystectomy

Без фазы С лечением Postoperative Pain Laparoscopic Cholecystectomy

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: Ultrasound-guided subcostal TAP block combined with rectus sheath block.
Кому может быть актуально
Состояния в реестре: Postoperative Pain, Laparoscopic Cholecystectomy. 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
South Korea
Следующий шаг
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Официальное название

Effect of Timing of Ultrasound-Guided Subcostal Transversus Abdominis Plane Block Combined With Rectus Sheath Block on Postoperative Pain in Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial

Обзор

This prospective randomized controlled trial aims to evaluate whether the timing of ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) affects postoperative pain in patients undergoing laparoscopic cholecystectomy. Participants will be randomly assigned to receive the combined regional blocks either before surgical incision or after completion of surgery. The primary outcome is postoperative pain intensity measured using a numerical rating scale. Secondary outcomes include opioid consumption, incidence of postoperative nausea and vomiting, and other recovery parameters. The results of this study may help optimize the timing of abdominal wall blocks to improve postoperative analgesia and recovery following laparoscopic cholecystectomy.

Подробное описание

Postoperative pain after laparoscopic cholecystectomy remains a significant clinical concern despite the minimally invasive nature of the procedure. Ultrasound-guided abdominal wall blocks, including subcostal transversus abdominis plane (TAP) block and rectus sheath block (RSB), are widely used to reduce postoperative pain and opioid requirements. However, the optimal timing of block administration relative to surgical incision remains unclear.

This prospective, single-center, randomized controlled trial will compare the analgesic efficacy of pre-incisional versus post-operative administration of combined ultrasound-guided subcostal TAP block and RSB in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia.

Participants will be randomized in a 1:1 ratio using block randomization with randomly permuted block sizes. Standardized general anesthesia and postoperative analgesia protocols will be applied to all participants.

The primary outcome will be postoperative pain intensity measured using a numerical rating scale at predefined time points after surgery. Secondary outcomes will include cumulative opioid consumption, incidence of postoperative nausea and vomiting, rescue analgesic requirements, and recovery profiles.

The findings of this study are expected to provide evidence for optimizing the timing of abdominal wall block administration to improve postoperative analgesia and patient recovery after laparoscopic cholecystectomy.

Вмешательства

  • Процедура Ultrasound-guided subcostal TAP block combined with rectus sheath block
    Ultrasound-guided right subcostal transversus abdominis plane (TAP) block combined with bilateral rectus sheath block (RSB) is performed under sterile conditions using local anesthetic for postoperative analgesia.

Первичные конечные точки

  • Maximum postoperative pain intensity within 24 hours [Срок оценки: Within 24 hours after surgery]
Вторичные конечные точки (3)
  • Maximum postoperative pain intensity during post-anesthesia care unit stay [Срок оценки: During the post-anesthesia care unit stay]
  • Cumulative rescue opioid consumption within 24 hours [Срок оценки: Within 24 hours after surgery]
  • Incidence of postoperative nausea and vomiting [Срок оценки: Within 24 hours after surgery]

Критерии участия

Критерии включения

  • Elective laparoscopic cholecystectomy
  • Adults aged 18 to 80 years
  • Ability to understand the study procedures and provide informed consent
  • American Society of Anesthesiologists (ASA) physical status I-III

Критерии исключения

  • Presence of significant pain unrelated to the target disease that may interfere with pain assessment
  • Known allergy or contraindication to study medications (ropivacaine, acetaminophen, nefopam, or pethidine)
  • Planned single-port laparoscopic cholecystectomy
  • American Society of Anesthesiologists (ASA) physical status IV or higher
  • Infection of the abdominal wall or skin at the injection site, or anatomical abnormalities of the abdominal wall
  • Major neurological, psychiatric, or systemic diseases that may affect pain perception, treatment response, or study evaluation
  • Requirement for postoperative mechanical ventilation
  • Pregnancy or breastfeeding
  • Considered unsuitable for the study by the investigator
  • Refusal to participate or inability to provide informed consent

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

South Korea · 1 центр
  • Nowon Eulji University Hospital — Seoul

Идентификаторы

NCT: NCT07440940 · 2026-01-026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗