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临床试验/NCT07134608
NCT07134608已完成不适用

Classical Popliteal Sciatic Block Versus Crosswise Approach for Popliteal Sciatic (CAPS) Block in Below Knee Surgery:A Randomised Control Trial

National University of Malaysia2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年11月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
Pain score during positioning and block performance

研究概览

简要总结

Sensory and motor innervation below the knee is provided mainly by the popliteal-sciatic nerve except for a variable area of the medial leg supplied by the saphenous nerve. Regional anaesthesia and analgesia for below knee surgery are frequently provided by blocking the popliteal sciatic nerve in the popliteal fossa. Popliteal sciatic block was first introduced around the 1970s and has emerged as a popular technique for below knee surgery despite other types of lower limb peripheral nerve block. This is contributed because popliteal fossa offers a superficial and accessible location for nerve blockade. This anatomical feature simplifies the procedure and may reduce the risk of complications such as vascular puncture or nerve injury.

Analgesia provided by the popliteal sciatic block lasts significantly longer than with ankle blocks. One of the reasons is administration of local anaesthetic agent at the popliteal fossa allows it to bathe the sciatic nerve before it bifurcates into the tibial and common peroneal nerves, leading to a more extensive and prolonged nerve blockade. Besides the sciatic nerve at the popliteal level is encased in a common epineural sheath, which can facilitate the spread of the anaesthetic and prolong its effect. The popliteal sciatic block can be performed as a single-shot technique or as a continuous infusion via a catheter The success rate of popliteal sciatic block is dependent on several variables, including the operator's skill, patient considerations, and surgical variables.

This study comparing between 2 approaches of popliteal sciatic nerve ie: classical approach and relatively new approach that is crosswise approach of popliteal sciatic nerve (CAPS) block.

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
None

入排标准

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

入选标准

  • planned for either elective or non-elective unilateral below-knee surgery at HUKM
  • patients aged 18 years and older and classified as physical status I, II, or III as dictated by the American Society of Anaesthesiologists (ASA)

排除标准

  • included pregnant patients, those with a body mass index (BMI) ≥40 kg/m², contraindicated to peripheral nerve block (such as existing nerve injury to the limb intended for surgery), patient refusal, severe coagulopathy, local anaesthetic (LA) allergy, active infection at the intended block site, patients unable to provide a pain score using a verbal numerical rating scale (VNRS)

结局指标

主要结局

Pain score during positioning and block performance

时间窗: Time from positioning and block performance until completion of block (preoperative).

Using verbal numerical rating scale (VNRS),ranging from 0 to 10, where 0 = no pain and 10 = the worst pain imaginable.

次要结局

  • Fentanyl consumption(On operative day until post operative day 1)
  • Onset of block(Immediately after block completion until 30 minutes after.)
  • Failure rate(30 minutes after block completion)
  • Patient's satisfaction(One day after procedure.)
  • Complications(On operative day until post operative day 1)

研究者

发起方
National University of Malaysia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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