Minimum Effective Volume of Lidocaine-Bupivacaine for Subgluteal Block

Minimum Effective Volume of Lidocaine-Bupivacaine for Ultrasound-Guided Subgluteal Sciatic Nerve Block

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.

Study Overview

• Status: Unknown
• Conditions: Injuries to the Ankle and Foot
• Intervention / Treatment: Other: Subgluteal 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MontrealGH

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G-1A4
      • Recruiting
      • Montreal General Hospital
      • Contact: De QH Tran, MD, FRCPC; Phone Number: 43261 +15149341934; Email: de_tran@hotmail.com
      • Contact: Roderick J Finlayson, MD, FRCPC
      • Principal Investigator: De QH Tran, MD, FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Subgluteal sciatic block; Subgluteal block with similar volume	Other: Subgluteal Nerve Block; ultrasound-guided subgluteal sciatic nerve block.
Experimental: Subgluteal block; Subgluteal block with decreasing volume	Other: Subgluteal Nerve Block; ultrasound-guided subgluteal sciatic nerve block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate	minimal composite score of 6 out of 8 points	0-30 minutes

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: De Tran, MD, FRCPC, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: October 6, 2015
• First Posted (Estimate): October 8, 2015

Study Record Updates

• Last Update Posted (Estimate): June 13, 2016
• Last Update Submitted That Met QC Criteria: June 9, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: MGH