Ultrasound-guided Sciatic Nerve Block in Below Knee Amputation Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-07-01

Brief Summary

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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

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Detailed Description

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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

Conditions

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Sciatic Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

sciatic nerve block

Intervention Type PROCEDURE

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

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).

Group Type ACTIVE_COMPARATOR

sciatic nerve block

Intervention Type PROCEDURE

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

Interventions

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sciatic nerve block

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

Intervention Type PROCEDURE

Other Intervention Names

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sciatic nerve block at the subgluteal and popliteal region

Eligibility Criteria

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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).

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No