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临床试验/NCT05937256
NCT05937256已完成不适用

Quadratus Lumborum Block Versus Erector Spinae Plane Block As Analgesic Alternatives During Extracorporeal Shock Wave Lithotripsy

South Valley University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Analgesic Effect: cumulative opioid dose

研究概览

简要总结

This study is designed to compare analgesic effect of both the ultrasound (US)-guided QLB and ESPB blocks during ESWL and their effect on stone fragmentation.

详细描述

Urinary tract calculi, one of the most common benign urological diseases, is seen in 12% of patients and has a recurrence rate of approximately 50%.

Management of renal calculi is known to be affected by many factors, specially tolerance of pain during ESWL and how it is controlled.

Pain experienced during ESWL is thought to occur when shock waves from the lithotripter reach superficial structures such as skin and also deeper structures such as the ribs, nerves and the kidney capsule. There are three main factors that contribute to the propagation of pain at these structures: shock wave (SW) pressure, distribution, and focal area size .

Conventionally, pain during ESWL is managed by basic analgesics such as NSAIDs, which can also aid in stone clearance. Other methods of analgesia also have been studied and tested.

Quadratus lumborum block (QLB) was first described by Blanco in 2007, it blocks T7-L1 nerve fibres in most of the cases. Studies have reported its use in the management of postoperative pain after hip surgeries.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Informed written consent obtained
  • Age 18-60
  • American Society of Anesthesiologists(ASA) physical status: I, II
  • Stone pelvis less than 2.5 cm
  • Indicated for ESWL

排除标准

  • refusal of participation by parents or caregivers.
  • ASA physical status: > II
  • Stone pelvis >2.5 cm
  • Chronic pain
  • On chronic NSAID or opioid
  • Substance addict
  • Known local anesthetic drug sensitivity.
  • Preexisting infection at block site
  • Coagulopathy or anticoagulation.

研究组 & 干预措施

Group Q

Active Comparator

(n=30) will receive unilateral quadratus lumborum block type III

干预措施: Quadratus lumborum block type III (Procedure)

Group C

No Intervention

(n=30) will be control group receiving no intervention, managed only with conventional analgesia

Group E

Active Comparator

(n=30) will receive unilateral erector spinae plane block

干预措施: Erector spinae plane block (Procedure)

结局指标

主要结局

Analgesic Effect: cumulative opioid dose

时间窗: At 30 minutes

Comparing analgesic Effect of both QLB and ESPB by calculating the total opioid consumption over the total duration of session (approximately 30 minutes)

次要结局

  • Stone fragmentation: clearance rate(one week after ESWL session)
  • Adverse effects(immediately after 20 minutes of intervention)
  • Block failure rate(Immediately After 20 minutes of intervention)
  • The regional block time(procedure (At the end of intervention))
  • Feasibility of visualisation(procedure (At the end of intervention))
  • Stone fragmentation: shockwave energy(at 30 minutes)
  • Patient satisfaction(At 30 minutes)

研究者

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

Mohamed Gaber Ahmed

Lecturer in anesthesiology, intensive care and pain management

South Valley University

研究点 (2)

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