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临床试验/CTRI/2025/11/096866
CTRI/2025/11/096866尚未招募4 期

USG GUIDED PARA SACRAL ISCHIAL PLANE BLOCK VS POPLITEAL SCIATIC BLOCK IN IPSILATERAL BELOW KNEE SURGERIES : PROSPECTIVE RANDOMISED CONTROL STUDY

Medical college and SSG hospital , Vadodara1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2025年11月27日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
72
试验地点
1
主要终点
comparison of success rate between two different approaches of sciatic nerve block [parasacral ischial plane approach and popliteal sciatic approach]

研究概览

简要总结

The aim of study is compare efficacy between Parasacral ischial plane approach and popliteal sciatic approach for sciatic nerve block combining with femoral nerve block in ipsilateral below knee surgeries**.**

The patients will be randomly allocated into two groups by computer generated randomised software in opaque sealed envelope method in 1:1 ratio to undergo USG guided sciatic nerve block of either approach.

GROUP PIP : Patients will be given sciatic nerve block via parasacral ischial plane approach along with femoral nerve block under USG guidance.

GROUP PSB : Patients will be given sciatic nerve block via popliteal sciatic approach along with femoral nerve block under USG guidance .

Peripheral nerve stimulator will be used as aid for confirmation of needle tip placement near nerve component.

•Comparison of success rate between two different approaches of sciatic nerve block  as primary outcome.

•As a secondary outcome Duration of onset, time to achieve complete effect, Total duration of effect of sensory and motor block with duration  of  analgesia, Haemodynamic parameters like pulse, mean arterial pressure, SpO2, Peri-operative complications.

The proposed clinical research will compare two different techniques; those are parasacral ischial plane and popliteal sciatic approaches comparing sciatic nerve block characteristics for better efficacy,assessment of sensory and motor block, intra operative haemodynamic, post operative analgesia.

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 posted for ipsilateral below knee surgeries.
  • Weight 45 to 75 kg.
  • ASA II/III/IV.
  • Duration of surgery less than 3 hours.
  • Patients able to give written and informed consent.

排除标准

  • Patients not willing for procedure or unable to give consent.
  • Patients with coagulopathy, local infection, pre- existing neuropathy.
  • Patients allergic to local anaesthetics.
  • Patients with significant h/o drug or alcohol abuse, psychiatric illness.
  • Bilateral lower limb surgeries.

结局指标

主要结局

comparison of success rate between two different approaches of sciatic nerve block [parasacral ischial plane approach and popliteal sciatic approach]

时间窗: 30min

次要结局

  • Duration of onset, Time to achieve complete effect, Total duration of effect of sensory & motor block with duration of analgesia & hemodynamic parameters like pulse, mean arterial pressure, SpO2 with perioperative complications(30 mins)

研究者

发起方
Medical college and SSG hospital , Vadodara
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Akshay Parmar

SSG hospital , Vadodara / Goverment medical college , Vadodara

研究点 (1)

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