Ultrasound-guided Sciatic Nerve Block in Below Knee Amputation Surgery

NCT03394014 | Completed

• 1 other identifier: FMASU R46/2017
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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

Conditions

Sciatic Nerve Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• time taken to perform the block

  10-20 min

Study Arms (2)

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)

Procedure: sciatic nerve block

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).

Procedure: sciatic nerve block

Interventions

sciatic nerve block PROCEDURE

blocking sciatic nerve either at the subgluteal area or the popliteal region for effective anesthesia and analgesia during below knee amputation

Also known as: sciatic nerve block at the subgluteal and popliteal region

popliteal sciatic nerve block; subgluteal sciatic nerve block

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: December 24, 2017
• First Posted: January 9, 2018
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01