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临床试验/CTRI/2020/11/029435
CTRI/2020/11/029435已完成不适用

A randomised comparative evaluation of ultrasound guided classical versus parasacral parallel shift (PSPS) technique of sciatic nerve block combined with femoral nerve block as a sole anaesthetic modality for orthopaedic lower limb surgeries

PGIMER1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2020年1月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
PGIMER
入组人数
154
试验地点
1
主要终点
To compare success of sciatic nerve block using classical and parasacral parallel shift approach. Successful block will be defined when both motor and sensory block is established

研究概览

简要总结

Combined femoral and sciatic nerve block were initially administered for post-operative analgesia after major lower limb surgery.6 They were administered either as a single injection technique or as a continuous catheter technique.7 Various studies exist regarding the safety of combined femoral and sciatic nerve block over general and central neuraxial blocks for lower limb surgeries. 8,9.It is the primary anaesthetic modality in critically ill patients where both GA and central neuraxial block carry a high risk of mortality.10 The primary aim of this study is to compare the success of the parasacral sciatic nerve block with the classical and PSPS approach when combined with the USG femoral nerve block and administered as a sole anaesthetic agent for OLLS. The secondary aim of the study will be to compare the time to onset and intensity of sensory and motor blockade, time to first rescue analgesia and average pain scores at 6,12 and 24 hours post-operatively.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing traumatic lower limb orthopaedic surgery ASA physical status 1-3.

排除标准

  • a) Patient refusal for nerve blocks b) Allergy to amide local anaesthetic drugs c) Chronic opioid therapy d) Patients with thrombocytopenia/coagulopathy, on anti-coagulant and thrombolytic therapy g) Morbid obesity (BMI>35 with obesity symptoms or BMI > 40) h) Neurological diseases i) Infections in the intervention site j) Patients with psychiatric illness.

结局指标

主要结局

To compare success of sciatic nerve block using classical and parasacral parallel shift approach. Successful block will be defined when both motor and sensory block is established

时间窗: 30 minutes after performance of the block

次要结局

  • Dynamic and static pain in NRS(6hrs, 12hrs and 24hrs postoperatively)

研究者

发起方
PGIMER
申办方类型
Research institution and hospital

研究点 (1)

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