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临床试验/NCT07366138
NCT07366138招募中不适用

Ultrasound-Guided External Oblique Intercostal Plane Block Versus Subcostal Transversus Abdominis Plane Block For Perioperative Analgesia in Laparoscopic Sleeve Gastrectomy

Benha University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年11月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Total morphine consumption

研究概览

简要总结

This study aims to compare the analgesic efficacy, duration of analgesia, and overall opioid consumption between the external oblique intercostal plane (EOIP) block and subcostal transversus abdominis plane (TAP) block in patients undergoing laparoscopic sleeve gastrectomy.

详细描述

Postoperative pain management is a critical aspect of enhanced recovery after surgery (ERAS) protocols, particularly in laparoscopic bariatric procedures such as sleeve gastrectomy.

Among the ultrasound-guided abdominal wall blocks, the transversus abdominis plane (TAP) block and its subcostal variant have demonstrated efficacy for upper abdominal surgeries. The subcostal TAP block provides analgesia for the T6-T9 dermatomes, covering incisions in upper abdominal procedures like laparoscopic cholecystectomy and bariatric surgery.

The external oblique intercostal plane (EOIP) block is a relatively new fascial plane block that targets the intercostal nerves lying between the external oblique and intercostal muscles.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 65 years.
  • Both genders.
  • American Society of Anesthesiologists (ASA) class I or II
  • Body mass index (BMI) between 30-50 kg/m².
  • Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia.
  • Written informed consent from patients or surrogate decision makers.

排除标准

  • Patient refusal.
  • Allergy to local anesthetics.
  • Coagulation disorders or anticoagulant therapy.
  • Local infection or scar at the injection site.
  • Severe hepatic or renal dysfunction.
  • Chronic opioid use or psychiatric illness interfering with pain assessment.
  • Conversion to open surgery or intraoperative complications requiring re-exploration.

研究组 & 干预措施

EOIP Group (Group A )

Experimental

Patients will receive an ultrasound-guided bilateral external oblique intercostal plane (EOIP) block using 20 mL of 0.25% bupivacaine in each side after induction of anesthesia and prior to surgical incision.

干预措施: External oblique intercostal plane block (Other)

Subcostal TAP Group (Group T)

Experimental

Patients will receive a bilateral subcostal transversus abdominis plane (TAP) block using 20 mL of 0.25% bupivacaine in each side, under ultrasound guidance and identical conditions.

干预措施: Subcostal transversus abdominis plane block (Other)

结局指标

主要结局

Total morphine consumption

时间窗: 24 hours postoperatively

Patient-controlled analgesia (PCA) using intravenous morphine (1 mg bolus, 10-minute lockout) will be available for rescue analgesia when visual analogue score ( VAS ) \> 3.

次要结局

  • Time to first rescue analgesia(24 hours postoperatively)
  • Degree of pain(24 hours postoperatively)
  • Heart rate(Till the end of surgery (Up to two hours))
  • Mean arterial blood pressure(Till the end of surgery (Up to two hours))
  • Incidence of postoperative nausea and vomiting(24 hours postoperatively)
  • Block-related complications(24 hours postoperatively)
  • Degree of patient satisfaction(24 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Alaa El din Ali

Resident of Anesthesiology, Egypt.

Benha University

研究点 (1)

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