NCT02429141

Brief Summary

In the transarterial technique for axillary brachial plexus block, the axillary artery is intentionally punctured to indicate placement of the needle within the neurovascular sheath; local anesthetic is then injected deep and superficial to the axillary artery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

April 19, 2015

Last Update Submit

August 26, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Block procedure time for the axillary brachial plexus block

    time of the block achievement will be recorded up to 15 minutes

Secondary Outcomes (3)

  • Onset of the block

    outcome measure will be measured up to 30 minutes a

  • Time to request pain medication

    participants will be followed for 3 days

  • Block success rate

    participants success or block failure within 24 hours

Study Arms (2)

US-guided periarterial techique

EXPERIMENTAL

Axillary brachial plexus block by an ultrasound-guided periarterial technique

Procedure: US-guided periarterial techique

US-guided multi-injection technique

EXPERIMENTAL

Ultrasound-guided multi-injection perineural technique for axillary brachial plexus

Procedure: US-guided multi-injection technique

Interventions

The needle will be inserted in the axillary fossa in-plane (cranial to caudal) close to the intersection of the pectoralis and biceps muscles. Two separate injections of local anesthetic will be made deep and superficial to the axillary artery

US-guided periarterial techique

The median, ulnar and radial nerves will be identified by ultrasound. Local anesthetic will be injected adjacent to each nerve

US-guided multi-injection technique

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients (ASA physical status I-III) scheduled to undergo hand or wrist surgery under axillary brachial plexus block

You may not qualify if:

  • Patients with pre-existing neuropathy
  • Patients with allergy to local anesthetics
  • Patients with prior surgery in the ipsilateral axilla
  • Pregnant patients
  • Patients with difficulties in communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology Ziekenhuis Oost-Limburg

Genk, Belgium

Location

Study Officials

  • Admir Hadzic, MD

    Director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Catherine Vanderpitte, MD

Study Record Dates

First Submitted

April 19, 2015

First Posted

April 29, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

August 29, 2016

Record last verified: 2016-08

Locations