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临床试验/CTRI/2025/08/093555
CTRI/2025/08/093555
尚未招募
2 期

Comparison of ultrasound guided anterior quadratus lumborum block versus subcostal approach to anterior quadratus lumborum block on post operative analgesia in patients undergoing percutaneous nephrolithotomy- Double blinded randomized controlled trial.

Sri Manakula Vinayagar Medical College1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年9月5日最近更新:

概览

阶段
2 期
状态
尚未招募
发起方
Sri Manakula Vinayagar Medical College
入组人数
64
试验地点
1
主要终点
To compare the block duration by determining the time taken for first rescue analgesic between ultrasound guided anterior quadratus lumborum block and subcostal approach to anterior quadratus lumborum block.

概览

简要总结

All participants will undergo detailed clinical evaluation, including history, examination, routine and relevant investigations, and pre-anaesthetic assessment on the day prior to surgery. Patients will be briefed about the Numeric Rating Scale (0–10) for pain assessment and randomly allocated into two groups using block randomization: Group C (Conventional anterior quadratus lumborum block) and Group S (Subcostal anterior quadratus lumborum block). Written informed consent will be obtained.

Following standard intraoperative monitoring and spinal anaesthesia (17.5 mg of 0.5 percentage hyperbaric Bupivacaine at L3–L4), patients will undergo percutaneous nephrolithotomy in the prone position. At the end of surgery, Group C will receive a conventional anterior quadratus lumborum block and Group S will receive a subcostal approach, both under ultrasound guidance using 20 ml of 0.25 percentage Bupivacaine. The block technique and time will be recorded.

Postoperative pain will be assessed using NRS at rest (2, 4, 8, 12, 24 hours) and during movement (12, 24 hours). Rescue analgesia (IV Tramadol 0.5 mg/kg) will be administered if NRS greater than or equal to 4, with total 24-hour consumption noted. Hemodynamic parameters and side effects such as nausea, vomiting, site pain, hematoma, or local anaesthetic toxicity will be monitored. All outcome assessments will be done by a blinded observer.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)

入选标准

  • Asa Ps I,Ii,Iii -Either Gender -Patient Posted For Elective Percutaneous Nephrolithotomy.

排除标准

  • INFECTION AT INJECTION SITE -HYPERSENSITIVITY TO LOCAL ANAESTHETICS -SURGERY DONE UNDER GENERAL ANAESTHESIA.

结局指标

主要结局

To compare the block duration by determining the time taken for first rescue analgesic between ultrasound guided anterior quadratus lumborum block and subcostal approach to anterior quadratus lumborum block.

时间窗: 2hours,4hours,8hours,12hours, 24hours

次要结局

  • 1.To compare the pain scores at rest (resting numeric rating scale score) at specific time intervals post-operatively.(2.To compare the pain scores at ambulation (Dynamic numeric rating scale score) at 12hrs and 24hrs.)

研究者

发起方
Sri Manakula Vinayagar Medical College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Anjana

Sri Manakula Vinayagar Medical College Madagadipet Kalatheerthalkuppam

研究点 (1)

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