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临床试验/CTRI/2025/08/092134
CTRI/2025/08/092134尚未招募不适用

Ultrasound guided popliteal sciatic nerve block: A comparison of separate injections to tibial and common peroneal nerve versus injection proximal to the bifurcation.

Vinayaka Missions Kirupananda Variyar Medical College and Hospitals1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To evaluate and compare the onset times and success rates of ultrasound guided popliteal sciatic nerve block done by two different techniques:

研究概览

简要总结

This is a prospective, randomized clinical study designed to compare two ultrasound-guided techniques for performing the popliteal sciatic nerve block in patients undergoing elective foot or ankle surgery. The primary objective is to compare the onset time and success rate of the nerve block between the two techniques: (1) separate injections around the tibial and common peroneal nerves distal to the bifurcation, and (2) a single injection proximal to the bifurcation.

Secondary objectives include comparison of the duration of blockade, postoperative pain scores, and the incidence of adverse events.

All patients will receive a standardized local anesthetic mixture (levobupivacaine 0.5% with dexmedetomidine), and blocks will be administered under ultrasound guidance by experienced anesthesiologists. Outcome assessments will be performed by a blinded observer.

The study aims to assess whether targeting the distal nerve branches leads to a faster onset and more effective blockade, thereby identifying the optimal technique for regional anesthesia in foot and ankle surgeries.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective foot or surgery
  • Age group: 18 to 60 years
  • American Society of Anesthesiologists Physical Status (ASA-PS) I, II and III
  • Both male and female patients
  • Patient providing written informed consent.

排除标准

  • American Society of Anesthesiologists Physical Status (ASA-PS) IV or higher
  • Age less than 18 or more than 60 years
  • Patient refusal or inability to provide informed consent
  • Known allergy or hypersensitivity to local anesthetics
  • Infection, cellulitis, or skin lesions at the site of injection (popliteal region)
  • Pre-existing neurologic or neuromuscular disease
  • Obstetric patients.

结局指标

主要结局

To evaluate and compare the onset times and success rates of ultrasound guided popliteal sciatic nerve block done by two different techniques:

时间窗: Block progression is assessed every 3 minutes till complete blockade for onset time. | Success rate is observed at the end of surgery.

1) separate injections around tibial and common peroneal branches distal to the bifurcation, and 2) single injection around the sciatic nerve proximal to its bifurcation.

时间窗: Block progression is assessed every 3 minutes till complete blockade for onset time. | Success rate is observed at the end of surgery.

次要结局

  • To compare the block procedure time, post-operative pain & incidence of adverse events associated with ultrasound guided popliteal sciatic nerve block done by separate tibial & common peroneal branches injections compared to injecting proximal to the bifurcation.(Block procedure time is from USG probe preparation to deposition of local anesthetic.)

研究者

发起方
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr V A Sabapathy

Vinayaka Missions Kirupananda Variyar Medical College and Hospitals

研究点 (1)

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