4-Point TAP Block vs. Combined RSB-OSTAP Block for Recovery After Laparoscopic Cholecystectomy

Официальное название

Comparison of 4-Point Transversus Abdominis Plane Block and Combined Bilateral Rectus Sheath-Oblique Subcostal TAP Block on Quality of Recovery After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Обзор

Laparoscopic cholecystectomy is a common keyhole surgery to remove the gallbladder. Although the cuts are small, patients can still have significant pain and nausea after the operation, which may delay recovery and discharge. To improve comfort, doctors often use ultrasound-guided abdominal nerve blocks as part of multimodal pain management. In this single-center, randomized controlled trial, adult patients scheduled for elective laparoscopic cholecystectomy will receive standard general anesthesia and be randomly assigned to one of two routinely used block techniques at the end of surgery: (1) a 4-point transversus abdominis plane (TAP) block, or (2) a combined bilateral rectus sheath block plus oblique subcostal TAP block. Both techniques are performed under ultrasound guidance while the patient is still asleep. The main aim of the study is to compare the quality of recovery on the first day after surgery between the two groups, using a short questionnaire (QoR-15). Secondary aims are to compare pain scores, the need for additional pain medicine, and the frequency of postoperative nausea and vomiting between the groups during the first 24 hours. All other aspects of anesthesia and surgical care will follow standard hospital practice. Participation is not expected to add significant risk beyond that of routine anesthesia and surgery, as both block techniques are already commonly used in clinical practice.

Вмешательства

• Процедура 4-Point TAP (4QTAP) Group
  4-Point TAP (4QTAP) Group: Ultrasound-guided 4-point transversus abdominis plane block will be performed at two subcostal and two lateral injection points. A total of 40 mL of 0.25% bupivacaine will be administered (10 mL at each point).
• Процедура RSB + OSTAP Group
  RSB + OSTAP Group: Ultrasound-guided bilateral rectus sheath block (two injection points) combined with bilateral oblique subcostal TAP block (two injection points) will be performed. A total of 40 mL of 0.25% bupivacaine will be administered (10 mL at each point).

Первичные конечные точки

• Quality of Recovery score (QoR-15) [Срок оценки: 24 hours]

Вторичные конечные точки (3)

• Postoperative pain score (VAS) [Срок оценки: 30 minutes, 2 hours, 8 hours, and 24 hours after surgery.]
• Incidence of postoperative nausea and vomiting (PONV) [Срок оценки: First 24 hours postoperative.]
• Antiemetic requirement [Срок оценки: First 24 hours postoperative.]

Критерии участия

Критерии включения

Adults aged 18-65 years

ASA physical status I-II

Scheduled for elective laparoscopic cholecystectomy

Ability to understand the study and provide written informed consent

Критерии исключения

Allergy or hypersensitivity to local anesthetics or study medications

Coagulopathy, anticoagulant therapy, or local infection at block site

Severe pulmonary disease (severe COPD, uncontrolled asthma, respiratory failure)

NYHA class III-IV heart failure

History of thoracic or abdominal surgery affecting block area

Chronic pain syndrome or regular opioid/analgesic use

Morbid obesity (BMI > 35 kg/m²)

Pregnancy or breastfeeding

Cognitive impairment preventing cooperation

Conversion to open cholecystectomy

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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

Turkey (Türkiye) · 1 центр

• Konya City Hospital — Konya

Идентификаторы

NCT: NCT07264608 · 4TAB-RSB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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