Ultrasound-guided Sciatic Nerve Block in Below Knee Amputation Surgery

Not Applicable

Completed

• Conditions: Sciatic Nerve Block
• Interventions: Procedure: sciatic nerve block

• Registration Number: NCT03394014
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-01
• Study First Submitted: 2017-12-24
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-03
• Last Update Submitted: 2018-01-03
• Study First Posted: 2018-01-09
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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

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Exclusion Criteria

• 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
popliteal sciatic nerve block	sciatic nerve block	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)
subgluteal sciatic nerve block	sciatic nerve block	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).

Primary Outcome Measures

Name	Time	Method
to compare between the two techniques as regards the success rate.	24 hours	Success was considered when the block provided solid analgesia with no need to shift to GA

Secondary Outcome Measures

Name	Time	Method
time taken to perform the block	10-20 min	time required to perform either block