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Clinical Trials/NCT02334176
NCT02334176
Unknown
Not Applicable

A Prospective, Randomized Comparison Between Single and Double Injection Ultrasound-Guided Axillary Brachial Plexus Block

Institut Kassab d'Orthopédie0 sites320 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Ultrasound guided axillary plexus block with 1 injection
Conditions
Anesthesia
Sponsor
Institut Kassab d'Orthopédie
Enrollment
320
Primary Endpoint
Success rate
Last Updated
11 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
July 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut Kassab d'Orthopédie
Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

single injection

Axillary plexus block performed with single injection dorsally to the artery

Intervention: Ultrasound guided axillary plexus block with 1 injection

single injection

Axillary plexus block performed with single injection dorsally to the artery

Intervention: lidocaine 1.5% with epinephrine 5µg/ml

Double injection

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

Intervention: Ultrasound guided axillary plexus block with 2 injections

Double injection

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

Intervention: lidocaine 1.5% with epinephrine 5µg/ml

Outcomes

Primary Outcomes

Success rate

Time Frame: 2 hours after the block performance

the percentage of patients who successfully complete surgery without any additional anesthesia. Will be assessed at the end of the surgery with an expected average time of 2 hours.

total anesthesia-related time

Time Frame: <30 minutes after the block performance

The total anesthesia-related time is the sum of performance and onset time (see below).

Secondary Outcomes

  • number of needle passes(5 minutes)
  • imaging time(5 minutes)
  • Onset time(every 5 minutes until 30 minutes after the end of the block performance)
  • needling time(5 minutes)
  • Sensory blockade(every 5 minutes until 30 minutes after the end of the block performance)
  • Performance time(10 minutes)
  • Motor blockade(every 5 minutes until 30 minutes after the end of the block performance)
  • Composite score(every 5 minutes until 30 minutes after the end of the block performance)

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