US Guided Axillary Block With Only One Injection

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

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-07-31

Brief Summary

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The investigators conducted this prospective, randomized, observer-blinded, non-inferiority trial to compare single perivascular injection to double injection (musculocutaneous nerve and perivascular injection) US guided axillary brachial plexus block.

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Detailed Description

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The investigators have been challenged by the question of whether all a single injection may be enough to successfully perform a axillary plexus block.

Three hundred and twenty patients undergoing elective hand surgery under axillary brachial plexus block will be enrolled into this prospective, randomized, observer-blinded non inferiority trial. Using a computer-generated sequence of random numbers and sealed envelope technique, the patients included will randomly be allocated to receive either single or double injection ultrasound-guided axillary block. The block will be performed with the in-plane technique using a 22 gauge, 50 mm needle and a high frequency linear probe.

In the 2 injection group, the needle will initially be advanced toward musculocutaneous nerve and 7 ml of LA (lidocaine 1.5% with epinephrine 5µg/ml) will be deposited around the nerve. The needle will be then advanced until the tip will be positioned just dorsal to the artery and 28 ml of (lidocaine 1.5% with epinephrine 5µg/ml) will be deposited in this location. In the single injection group using the same LA, and 35 ml will be deposited dorsal the artery.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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single injection

Axillary plexus block performed with single injection dorsally to the artery

Group Type ACTIVE_COMPARATOR

Ultrasound guided axillary plexus block with 1 injection

Intervention Type PROCEDURE

The needle will be advanced until the tip is positioned just dorsal to the artery and 35ml of (lidocaine 1.5% with epinephrine 5µg/ml) is deposited in this location.

lidocaine 1.5% with epinephrine 5µg/ml

Intervention Type DRUG

35 ml of lidocaine 1.5% with epinephrine 5µg/ml will be used to perform the axillary plexus block

Double injection

Axillary plexus block performed with 2 injections: one over musculocutaneous nerve the second one dorsally to the artery

Group Type ACTIVE_COMPARATOR

Ultrasound guided axillary plexus block with 2 injections

Intervention Type PROCEDURE

The needle will be initially advanced toward musculocutaneous nerve and 7 ml of LA (lidocaine 1.5% with epinephrine 5µg/ml) is deposited around the nerve. The needle will be then advanced until the tip is positioned just dorsal to the artery and 28 ml of (lidocaine 1.5% with epinephrine 5µg/ml) is deposited in this location.

lidocaine 1.5% with epinephrine 5µg/ml

Intervention Type DRUG

35 ml of lidocaine 1.5% with epinephrine 5µg/ml will be used to perform the axillary plexus block

Interventions

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Ultrasound guided axillary plexus block with 1 injection

The needle will be advanced until the tip is positioned just dorsal to the artery and 35ml of (lidocaine 1.5% with epinephrine 5µg/ml) is deposited in this location.

Intervention Type PROCEDURE

Ultrasound guided axillary plexus block with 2 injections

The needle will be initially advanced toward musculocutaneous nerve and 7 ml of LA (lidocaine 1.5% with epinephrine 5µg/ml) is deposited around the nerve. The needle will be then advanced until the tip is positioned just dorsal to the artery and 28 ml of (lidocaine 1.5% with epinephrine 5µg/ml) is deposited in this location.

Intervention Type PROCEDURE

lidocaine 1.5% with epinephrine 5µg/ml

35 ml of lidocaine 1.5% with epinephrine 5µg/ml will be used to perform the axillary plexus block

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-75 year of age, ASA physical status I-III, BMI 25 to 35 Kg/m2

Exclusion Criteria

* non consents patients, any contraindication to brachial plexus anesthesia (local anesthetic allergy, local infection and coagulopathy), preexisting neuropathy, hepatic or renal failure, pregnancy and surgery in the axillary region.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No