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临床试验/CTRI/2025/11/097342
CTRI/2025/11/097342尚未招募1/2 期

Efficacy of external and rectus abdominus plane (EXORA) block versus subcostal transversus abdominus plane(TAP) block in laaroscopic cholecystectomy surgeries

Armed Forces Medical College Pune1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月24日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1. To evaluate and compare time to first rescue analgesic request between the EXORA block and subcostal TAP block groups in patients undergoing laparoscopic cholecystectomy

研究概览

简要总结

The methodology for this prospective, randomized, double-blinded, comparative study will commence with patient enrollment at a tertiary care hospital in Western Maharashtra, where adult patients scheduled for elective laparoscopic cholecystectomy under general anesthesia will be screened for eligibility based on inclusion and exclusion criteria. Eligible patients, aged 18–65 years with ASA physical status I or II and BMI < 35 kg/m², will provide written informed consent following a detailed explanation of the study. Patients will be allocated to one of two groups—Group A (EXORA block) or Group B (subcostal TAP block)—using block randomization with allocation concealment ensured via sealed opaque envelopes.

Prior to surgery, bilateral blocks will be administered under ultrasound guidance by an experienced anaesthesiologist using a high-frequency linear probe (6–13 MHz). For the EXORA block group, 15 mL of 0.25% bupivacaine (total 30 mL per side) will be injected into the fascial plane between the external oblique and rectus abdominis muscles, targeting the T6–T9 anterior cutaneous branches of the thoracoabdominal nerves. For the subcostal TAP block group, the same volume and concentration of bupivacaine will be deposited between the internal oblique and transversus abdominis muscles, targeting the T6–T12 thoracic intercostal nerves.

A standardized general anesthesia protocol will be followed, using propofol (2–3 mg/kg), fentanyl (2 µg/kg), and rocuronium (0.6–1 mg/kg) for induction, and sevoflurane (1–2%) for maintenance, with surgery performed via a standard four-port laparoscopic cholecystectomy technique.

Postoperatively, patients will receive intravenous paracetamol (1 g every 6 hours) as the first-line analgesic, with intravenous tramadol (50 mg) as rescue analgesia for VAS scores exceeding 4. Pain intensity at rest and during movement (coughing or sitting up) will be assessed using the Visual Analogue Scale (VAS, 0–10) at 30 minutes, 2, 4, 6, 12, and 24 hours post-surgery by blinded outcome assessors. Secondary outcomes, including time to first rescue analgesic request, total tramadol consumption (converted to morphine equivalents), block-related complications (e.g., haematoma,

vomiting), patient satisfaction (via a 5-point Likert scale), and block performance time, will be recorded in a structured proforma. Sensory blockade will be evaluated post-block using a pinprick test to confirm dermatomal coverage.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA I & II patients 18 years to 65 years ASA physical status I or II Patients undergoing elective laparoscopic cholecystectomy BMI less than 35 Consent to participate in the study.

排除标准

  • Patients who deny consent will not be included in the study Allergy to local anaesthetics Coagulopathy or anticoagulant therapy Infection at the site of block Chronic pain disorders or opioid use Conversion to open cholecystectomy Pregnancy.

结局指标

主要结局

1. To evaluate and compare time to first rescue analgesic request between the EXORA block and subcostal TAP block groups in patients undergoing laparoscopic cholecystectomy

时间窗: 18 months

次要结局

  • 1. To assess the postoperative pain scores using the Visual Analogue Scale (VAS) at specified time intervals within the first 24 hours between the study groups.(2. To monitor any block related complications or side effects between the study groups.)

研究者

发起方
Armed Forces Medical College Pune
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Naseef Sakkir

Armed Forces Medical College Pune

研究点 (1)

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