跳至主要内容
临床试验/NCT03394014
NCT03394014已完成不适用

Ultrasound -Guided Sciatic Nerve Block in Below Knee Amputation Surgery: Subgluteal Versus Popliteal

Ain Shams University0 个研究点目标入组 56 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
主要终点
to compare between the two techniques as regards the success rate.

研究概览

简要总结

56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee amputation were randomly assigned to receive either sciatic nerve block using a popliteal approach or a sub gluteal approach. Patients in both groups received same amount of LA and additional ultrasound guided femoral nerve block to ensure sensory block of the medial side of the leg. Success of the block was considered when the block is solid and doesn't require shifting to GA

详细描述

56 ASA physical status II and III patients, aged 45-75 year, undergoing elective below knee amputation were randomly assigned to receive either sciatic nerve block using a popliteal approach (group P, n 28) or a sub gluteal approach (group G, n 28). Patients in both groups received same amount of LA (25 ml of bupivacaine 0.5 %) and additional ultrasound guided femoral nerve block by 10 ml of bupivacaine 0.5% to ensure sensory block of the medial side of the leg. Time to complete sensory and motor block, time taken to perform the block, block-related complications, block duration, time for asking for rescue analgesia in the first 24 h were recorded and both patients and surgeons were asked about their level of satisfaction. Success of the block was considered when the block is solid and doesn't require shifting to GA

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status II and III patients
  • aged 45-75 years,
  • undergoing elective below knee amputation

排除标准

  • patients who refused to participate in the study,
  • those having allergy to local anaesthetics,
  • or having contraindications to regional anaesthesia (having neurologic or neuromuscular disease, on anticoagulation therapy, or having skin infection at the site of needle insertion).

研究组 & 干预措施

popliteal sciatic nerve block

Active Comparator

injecting 25 ml of bupivacaine 0.5 % (Sunnypivacaine, 20 ml vial contains Bupivacaine HCL Monohydrate 105.5 mg eq. to 100 mg Bupivacaine HCL, Sunny Pharmaceutical, Badr city- Cairo- Egypt) once circumferentially around the sciatic nerve at the popliteal fossa using ultrasound device (S-Nerve ultrasound system, Fujifilm Sonosite Inc., Bothell, WA)

干预措施: sciatic nerve block (Procedure)

subgluteal sciatic nerve block

Active Comparator

injecting 25 ml of bupivacaine 0.5 % (Sunnypivacaine, 20 ml vial contains Bupivacaine HCL Monohydrate 105.5 mg eq. to 100 mg Bupivacaine HCL, Sunny Pharmaceutical, Badr city- Cairo- Egypt) circumferentially around the sciatic nerve at the subgluteal region using ultrasound device (S-Nerve ultrasound system, Fujifilm Sonosite Inc., Bothell, WA).

干预措施: sciatic nerve block (Procedure)

结局指标

主要结局

to compare between the two techniques as regards the success rate.

时间窗: 24 hours

Success was considered when the block provided solid analgesia with no need to shift to GA

次要结局

  • time taken to perform the block(10-20 min)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rania Maher Hussien

principle investigator

Ain Shams University

相似试验