跳至主要内容
临床试验/CTRI/2025/09/094311
CTRI/2025/09/094311
尚未招募
2 期

Comparision of post-operative analgesic efficacy of Erector spinae plane block with Retrolaminar block in patients undergoing Percutaneous Nephrolithotomy

Vardhman Mahavir Medical College and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月1日最近更新:

概览

阶段
2 期
状态
尚未招募
发起方
Vardhman Mahavir Medical College and Safdarjung Hospital
入组人数
80
试验地点
1
主要终点
To compare the post-operative analgesic efficacy of erector spinae plane block with Retrolaminar block in patients undergoing Percutaneous Nephrolithotomy under general anaesthesia using Visual Analogue Scale score

概览

简要总结

This prospective randomized study will compare the postoperative analgesic efficacy of ultrasound-guided erector spinae plane block and retrolaminar block in 80 ASA I–II patients aged 18–65 years undergoing percutaneous nephrolithotomy (PCNL), a procedure associated with significant postoperative pain. While opioids and epidural analgesia are effective, their adverse effects limit routine use, and newer interfascial plane blocks such as erector spinae plane block and retrolaminar block offer safer alternatives, though direct comparative evidence is scarce. Patients will be randomized to receive either erector spinae plane block or retrolaminar block with 20 mL of 0.25% bupivacaine under ultrasound guidance. The primary outcome will be analgesic efficacy, assessed by Visual Analogue Scale (VAS) scores at rest and deep breathing at 1, 4, 8, and 24 hours postoperatively. Secondary outcomes include intraoperative fentanyl consumption, time to first rescue analgesia, total tramadol requirement in 24 hours, postoperative nausea and vomiting, block-related complications, and patient satisfaction using the Likert scale. The study aims to establish whether retrolaminar block provides analgesia comparable to erector spinae plane block with a favorable safety profile, thereby guiding optimal pain management strategies in PCNL.

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

  • Patients of either gender with American Society of Anaesthesiologists (ASA) physical status Grade I and II, aged 18-65years, undergoing PCNL surgery.

排除标准

  • Patients with contraindication to blocks (coagulopathies/ on anticoagulants/ local site infection)
  • Patients with history of allergy to local anaesthetic agents.
  • 3.Patients who have cognitive disability / are unable to understand the VAS score.

结局指标

主要结局

To compare the post-operative analgesic efficacy of erector spinae plane block with Retrolaminar block in patients undergoing Percutaneous Nephrolithotomy under general anaesthesia using Visual Analogue Scale score

时间窗: At 1,4,8 and 24 hours postoperatively

次要结局

  • To compare the intraoperative Fentanyl requirement
  • To compare the time to the first rescue analgesia
  • To compare the amount of additional analgesia required post operatively
  • To compare the patient satisfaction scores post-operatively using Likert scale

研究者

发起方
Vardhman Mahavir Medical College and Safdarjung Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Shah Hemali Bhavin

Vardhman Mahavir Medical College and Safdarjung Hospital

研究点 (1)

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