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Набор скоро начнётся NCT07403682

M-TAPA vs ESPB for Postoperative Analgesia After Laparoscopic Cholecystectomy

Без фазы С лечением Postoperative Pain Cholecystectomy, Laparoscopic

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: Modifiye throcoabdominal nerve block through the perichondrial approach (M-TAPA), erector spinae plane block (ESPB).
Кому может быть актуально
Состояния в реестре: Postoperative Pain, Cholecystectomy, Laparoscopic. Базовые параметры: 18 лет — 65 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparison of M-TAPA and ESPB Blocks for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Обзор

Postoperative pain after laparoscopic cholecystectomy can negatively affect patient comfort, recovery, and opioid consumption. Regional abdominal wall blocks are commonly used as part of multimodal analgesia to improve postoperative pain control and reduce opioid-related side effects. The modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) and the erector spinae plane block (ESPB) are two ultrasound-guided regional anesthesia techniques that have been shown to provide effective postoperative analgesia in abdominal surgery. However, comparative clinical data between these two techniques in laparoscopic cholecystectomy are limited. This randomized, single-blind clinical trial aims to compare the postoperative analgesic effectiveness of M-TAPA and ESPB in adult patients undergoing elective laparoscopic cholecystectomy. Postoperative pain scores, opioid consumption, time to first analgesic requirement, and patient satisfaction will be evaluated.

Подробное описание

This study is designed as a prospective, randomized, single-blind controlled clinical trial conducted in adult patients scheduled for elective laparoscopic cholecystectomy. The primary objective of the study is to compare the postoperative analgesic effectiveness of the modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) and the erector spinae plane block (ESPB).

Eligible patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I-II will be randomly assigned in a 1:1 ratio to receive either M-TAPA or ESPB. Randomization will be performed using a computer-generated random number sequence, and allocation will be concealed in sealed, opaque envelopes to prevent selection bias.

All blocks will be performed under ultrasound guidance by experienced anesthesiologists using standard local anesthetic agents routinely applied in clinical practice. The study is designed as single-blind, with patients blinded to group allocation.

Postoperative pain intensity will be assessed using the visual analog scale (VAS) at 0, 1, 6, 12, and 24 hours after surgery. Additional outcome measures include total opioid consumption within the first 24 postoperative hours, time to first analgesic requirement, need for rescue analgesia, and patient satisfaction. Adverse events related to regional anesthesia techniques will be recorded.

The study follows the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. Ethical approval has been obtained from the relevant Clinical Research Ethics Committee prior to study initiation.

Вмешательства

  • Процедура Modifiye throcoabdominal nerve block through the perichondrial approach (M-TAPA)
    An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
  • Процедура erector spinae plane block (ESPB)
    An ultrasound-guided erector spinae plane block (ESPB) performed using local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.

Первичные конечные точки

  • Total Opioid Consumption in the First 24 Hours [Срок оценки: within the first 24 hours postoperatively]

Критерии участия

Критерии включения

  • Adult patients aged 18-65 years
  • ASA physical status I-III
  • Scheduled for elective surgery under general anesthesia
  • Ability to understand the study procedures and provide written informed consent

Критерии исключения

  • Refusal to participate
  • Known allergy to local anesthetics
  • Coagulation disorders or anticoagulant therapy
  • Infection at the injection site
  • Severe hepatic, renal, or cardiac disease
  • Chronic opioid use

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
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07403682 · BCS-MTAPA-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗