Clinical trial NCT02334176: US Guided Axillary Block With Only One Injection
Official title: A Prospective, Randomized Comparison Between Single and Double Injection Ultrasound-Guided Axillary Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Institut Kassab d'Orthopédie
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Success rate
timeFrame: 2 hours after the block performance
measure: total anesthesia-related time
timeFrame: <30 minutes after the block performance
Secondary outcomes:
measure: imaging time
timeFrame: 5 minutes
measure: needling time
timeFrame: 5 minutes
measure: number of needle passes
timeFrame: 5 minutes
measure: Performance time
timeFrame: 10 minutes
measure: Onset time
timeFrame: every 5 minutes until 30 minutes after the end of the block performance
measure: Sensory blockade
timeFrame: every 5 minutes until 30 minutes after the end of the block performance
measure: Motor blockade
timeFrame: every 5 minutes until 30 minutes after the end of the block performance
measure: Composite score
timeFrame: every 5 minutes until 30 minutes after the end of the block performance
Other outcomes:
measure: paresthesia and numbness
timeFrame: up to 48 hours postoperatively
measure: blood vessel puncture
timeFrame: 10 minutes
Locations:
Study officials:
affiliation: Kassab Institut of orthopedics
name: Olfa Kaabachi, M.D
role: STUDY_CHAIR
References:
citation: Ay S, Akinci M, Sayin M, Bektas U, Tekdemir I, Elhan A. The axillary sheath and single-injection axillary block. Clin Anat. 2007 Jan;20(1):57-63. doi: 10.1002/ca.20270.
citation: Kjelstrup T, Hol PK, Courivaud F, Smith HJ, Rokkum M, Klaastad O. MRI of axillary brachial plexus blocks: a randomised controlled study. Eur J Anaesthesiol. 2014 Nov;31(11):611-9. doi: 10.1097/EJA.0000000000000122.
citation: Tran DQ, Pham K, Dugani S, Finlayson RJ. A prospective, randomized comparison between double-, triple-, and quadruple-injection ultrasound-guided axillary brachial plexus block. Reg Anesth Pain Med. 2012 May-Jun;37(3):248-53. doi: 10.1097/AAP.0b013e31824611bf.