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临床试验/CTRI/2023/06/054154
CTRI/2023/06/054154尚未招募2/3 期

Evaluation of ultrasound assisted peripheral nerve stimulator guided versus peripheral nerve stimulator guided lumbosacral plexus block for postoperative analgesia in patients undergoing lower limb surgery

Department of Anaesthesia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月7日最近更新:

试验速览

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

研究概览

简要总结

This study is a prospective, randomized, parallel group trial comparing the efficacy of ultrasound assisted peripheral nerve stimulator guided versus peripheral nerve stimulator guided lumbosacral plexus block (LPSB) for postoperative analgesia in terms of patient satisfaction, time taken for the procedure, ease of administration, number of pricks, duration of analgesia, postoperative analgesic requirement and haemodynamic parameters associated with the procedure in patients undergoing elective unilateral lower limb surgery. The study will be conducted in Government Medical College, Amritsar on 60 ASA grade I-II patients of either sex in the age group of 20 to 60 years scheduled for lower limb orthopaedic surgery under spinal anaesthesia, randomly divided into two groups of 30 patients each- Group ’U’ will receive LSPB using ultrasound assisted peripheral nerve stimulator guided technique and Group ’P’ will receive LSPB using peripheral nerve stimulator guided technique. The data thus obtained will be analyzed and compared statistically.

研究设计

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

入排标准

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

入选标准

  • Patients belonging to ASA grade I and II Patients undergoing elective unilateral lower limb surgery Patients with normal neurological status Co-operative patients.

排除标准

  • Refusal by patient for the procedure or to enlist in study Patients belonging to ASA grade III or IV Patients with coagulation disorders or on anticoagulation therapy Patients with history of allergy to local anaesthetic drugs Local infection at the site of block Patients with known neuropathies Morbidly obese patients Pregnant females Patients undergoing bilateral lower limb surgery.

结局指标

主要结局

Procedural Time (Time required to complete the block)

时间窗: Time from start of procedure till 24 hours after surgery

Duration of sensory block

时间窗: Time from start of procedure till 24 hours after surgery

Total dose of rescue analgesia in 24 hours

时间窗: Time from start of procedure till 24 hours after surgery

Number of pricks taken in each block

时间窗: Time from start of procedure till 24 hours after surgery

次要结局

  • Haemodynamic changes(Side effects & complications including number of inadvertent vessels punctured)

研究者

申办方类型
Government medical college

研究点 (1)

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