Ultrasound-guided Sciatic Nerve Block in Below Knee Amputation Surgery

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

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

Study Overview

• Status: Completed
• Conditions: Sciatic Nerve Block
• Intervention / Treatment: Procedure: sciatic nerve block

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

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: popliteal 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)	Procedure: sciatic nerve block; blocking sciatic nerve either at the subgluteal area or the popliteal region for effective anesthesia and analgesia during below knee amputation; Other Names: sciatic nerve block at the subgluteal and popliteal region
ACTIVE_COMPARATOR: subgluteal 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).	Procedure: sciatic nerve block; blocking sciatic nerve either at the subgluteal area or the popliteal region for effective anesthesia and analgesia during below knee amputation; Other Names: sciatic nerve block at the subgluteal and popliteal region

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time taken to perform the block	time required to perform either block	10-20 min

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: December 24, 2017
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (ACTUAL): January 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 3, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: FMASU R46/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No