Minimum Effective Volume of Lidocaine-Bupivacaine for Subgluteal Block

Not Applicable

• Conditions: Injuries to the Ankle and Foot
• Interventions: Other: Subgluteal Nerve Block

• Registration Number: NCT02571699
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

The aim of this study is to determine the minimum effective volume of LA in 90 % of patients (MEV90) required for US-guided subgluteal sciatic nerve block.

Detailed Description

The aim of this study is to determine the minimum effective volume of LA in 90 % of patients (MEV90) required for US-guided subgluteal sciatic nerve block.

Success rate is defined as a minimal composite score of 6 points (out of 8 points) at 30 minutes.

Study Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-06
• Study First Posted: 2015-10-08
• Study Start: 2016-03
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-09
• Last Update Posted: 2016-06-13
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• age between 18 and 75 years
• American Society of Anesthesiologists classification 1-3
• body mass index between 20 and 35

Exclusion Criteria

• adults who are unable to give their own consent
• pre-existing neuropathy (assessed by history and physical examination)
• coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
• renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
• hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
• allergy to LA
• pregnancy
• prior surgery in the subgluteal region
• chronic pain syndromes requiring opioid intake at home

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subgluteal block	Subgluteal Nerve Block	Subgluteal block with decreasing volume
Subgluteal sciatic block	Subgluteal Nerve Block	Subgluteal block with similar volume

Primary Outcome Measures

Name	Time	Method
success rate	0-30 minutes	minimal composite score of 6 out of 8 points

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada