Minimum Effective Volume of Lidocaine-Bupivacaine for Subgluteal Block

McGill University

Status: Unknown

Conditions: Injuries to the Ankle and Foot

Treatments: Other: Subgluteal Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT02571699

MGH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Subgluteal sciatic block

Active Comparator group

Description:

Subgluteal block with similar volume

Treatment:

Other: Subgluteal Nerve Block

Subgluteal block

Experimental group

Description:

Subgluteal block with decreasing volume

Treatment:

Other: Subgluteal Nerve Block