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临床试验/CTRI/2024/07/071086
CTRI/2024/07/071086尚未招募2/3 期

Comparison of the efficacy of Ultrasound guided Popliteal nerve block versus Peripheral nerve stimulator technique for foot and ankle surgeries

Guru Nanak Dev Hospital Amritsar1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月31日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1.Procedural time (time required to complete the block)

研究概览

简要总结

Regional anaesthesia for lower limb surgeries has emerged as a target oriented approach as it has minimum side-effects, complications and is more cost effective. In lower limb surgeries popliteal block is a good alternative to subarachnoid block as it prevents the side-effects and complications particularly haemodynamical changes following subarachnoid block. Popliteal block can be given via prone approach or posterior approach. It can be performed using nerve stimulator technique or ultrasound technique. The present study aims to compare efficacy of popliteal block: ultrasound versus nerve stimulator technique for foot and ankle surgeries using prone approach in patients undergoing foot and ankle surgeries in Government medical college and hospital, Amritsar(Punjab). Patient will receive 30ml of 0.75% of injection ropivacaine for the block. The onset of sensory and motor block, procedure time will be assessed among the two techniques. Haemodynamics will be assessed. Intraoperative and postoperative complications will also be noted.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator 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 aged 18 to 60 years Both genders Asa grade I and II Patients with normal neurological status Patients undergoing foot and ankle surgeries.

排除标准

  • Refusal of patient for procedure or to enlist in surgery Patients of asa grade III and IV Uncooperative patients Pregnant females Patients with coagulation disorders and on anticoagulation therapy Patients with history of allergy to local anaesthetics Known neuropathies involving foot undergoing surgery.

结局指标

主要结局

1.Procedural time (time required to complete the block)

时间窗: 1.Time required to complete the block | 2.Sensory assessment of block at every 5 minutes interval | 3.Motor assessment of the block at every 5 minutes interval | 4.VAS score at 2,4,8,12,16,20,24 hours | 5.Number of inadvertent vessel puncture in each block | 6.Number of pricks taken in each block

2.Onset and grade of sensory block

时间窗: 1.Time required to complete the block | 2.Sensory assessment of block at every 5 minutes interval | 3.Motor assessment of the block at every 5 minutes interval | 4.VAS score at 2,4,8,12,16,20,24 hours | 5.Number of inadvertent vessel puncture in each block | 6.Number of pricks taken in each block

3.Onset and grade of motor block

时间窗: 1.Time required to complete the block | 2.Sensory assessment of block at every 5 minutes interval | 3.Motor assessment of the block at every 5 minutes interval | 4.VAS score at 2,4,8,12,16,20,24 hours | 5.Number of inadvertent vessel puncture in each block | 6.Number of pricks taken in each block

4.Success rate and adequacy of popliteal block and ratio of conversion to spinal anaesthesia

时间窗: 1.Time required to complete the block | 2.Sensory assessment of block at every 5 minutes interval | 3.Motor assessment of the block at every 5 minutes interval | 4.VAS score at 2,4,8,12,16,20,24 hours | 5.Number of inadvertent vessel puncture in each block | 6.Number of pricks taken in each block

5.VAS score

时间窗: 1.Time required to complete the block | 2.Sensory assessment of block at every 5 minutes interval | 3.Motor assessment of the block at every 5 minutes interval | 4.VAS score at 2,4,8,12,16,20,24 hours | 5.Number of inadvertent vessel puncture in each block | 6.Number of pricks taken in each block

次要结局

  • 1.Haemodynamic changes(2.Side effects & complications)

研究者

发起方
Guru Nanak Dev Hospital Amritsar
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Ravipaul Singh

Government Medical College, Amritsar

研究点 (1)

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