Minimum Effective Volume of Lidocaine-Bupivacaine for Subgluteal Block

NCT ID: NCT02571699

Last Updated: 2016-06-13

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Injuries to the Ankle and Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Subgluteal sciatic block

Subgluteal block with similar volume

Group Type ACTIVE_COMPARATOR

Subgluteal Nerve Block

Intervention Type OTHER

ultrasound-guided subgluteal sciatic nerve block.

Subgluteal block

Subgluteal block with decreasing volume

Group Type EXPERIMENTAL

Subgluteal Nerve Block

Intervention Type OTHER

ultrasound-guided subgluteal sciatic nerve block.

Interventions

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Subgluteal Nerve Block

ultrasound-guided subgluteal sciatic nerve block.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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De Tran

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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De Tran, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre/Research Institute of the McGill University Health Centre

Locations

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Montreal General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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MontrealGH

Role: CONTACT

Facility Contacts

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De QH Tran, MD, FRCPC

Role: primary

+15149341934 ext. 43261

Roderick J Finlayson, MD, FRCPC

Role: backup

Other Identifiers

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MGH

Identifier Type: -

Identifier Source: org_study_id

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