NCT02334176

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

December 30, 2014

Last Update Submit

January 7, 2015

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (2)

  • Success rate

    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.

    2 hours after the block performance

  • total anesthesia-related time

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

    <30 minutes after the block performance

Secondary Outcomes (8)

  • imaging time

    5 minutes

  • needling time

    5 minutes

  • number of needle passes

    5 minutes

  • Performance time

    10 minutes

  • Onset time

    every 5 minutes until 30 minutes after the end of the block performance

  • +3 more secondary outcomes

Other Outcomes (2)

  • paresthesia and numbness

    up to 48 hours postoperatively

  • blood vessel puncture

    10 minutes

Study Arms (2)

single injection

ACTIVE COMPARATOR

Axillary plexus block performed with single injection dorsally to the artery

Procedure: Ultrasound guided axillary plexus block with 1 injectionDrug: lidocaine 1.5% with epinephrine 5µg/ml

Double injection

ACTIVE COMPARATOR

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

Procedure: Ultrasound guided axillary plexus block with 2 injectionsDrug: lidocaine 1.5% with epinephrine 5µg/ml

Interventions

Ultrasound guided axillary plexus block with 1 injectionPROCEDURE

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.

single injection
Ultrasound guided axillary plexus block with 2 injectionsPROCEDURE

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.

Double injection
lidocaine 1.5% with epinephrine 5µg/mlDRUG

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

Double injectionsingle injection

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 16372345BACKGROUND

  • 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.

    PMID: 25051144BACKGROUND

  • 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.

    PMID: 22354104RESULT

MeSH Terms

Interventions

LidocaineEpinephrine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Olfa Kaabachi, M.D

    Kassab Institut of orthopedics

    STUDY CHAIR

Central Study Contacts

Karim Raies, M.D

CONTACT

+21655208602karim.raies@gmail.com

Imen Nefzi, M.D

CONTACT

+21621275799nefzi_imene@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2014

First Posted

January 8, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

January 8, 2015

Record last verified: 2015-01