US Guided Axillary Block With Only One Injection

Institut Kassab d'Orthopédie

Status: Unknown

Conditions: Anesthesia

Treatments: Drug: lidocaine 1.5% with epinephrine 5µg/ml; Procedure: Ultrasound guided axillary plexus block with 1 injection; Procedure: Ultrasound guided axillary plexus block with 2 injections

Study type: Interventional

Funder types: Other

Identifiers

NCT02334176

P2014/01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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320 participants in 2 patient groups

single injection

Active Comparator group

Description:

Axillary plexus block performed with single injection dorsally to the artery

Treatment:

Drug: lidocaine 1.5% with epinephrine 5µg/ml

Procedure: Ultrasound guided axillary plexus block with 1 injection

Double injection

Active Comparator group

Description:

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

Treatment:

Drug: lidocaine 1.5% with epinephrine 5µg/ml

Procedure: Ultrasound guided axillary plexus block with 2 injections