NCT03211949

Brief Summary

Blocking the medial antebrachial cutaneous nerve (MACN) during an axillary block often a subcutaneous wheal of local anesthetics is made what is described as painful. With the improvement of the resolution of the ultrasound machines smaller structures and nerves can be visable. In this study topographic assessment will made of the anatomical variation of the medial antebrachial cutaneous nerve (MACN) by ultrasound in the axilla and 5 cm above the cubital fossa of the arm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

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

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

5.3 years

First QC Date

October 30, 2014

Last Update Submit

August 4, 2022

Conditions

Keywords

axillary nerve block

Outcome Measures

Primary Outcomes (1)

  • anatomical mapping of the MACN relative to the basilic vein, radial nerve and ulnar nerve

    an ultrasound image will be stored with the structures marked

    up to 30 minutes

Study Arms (1)

axillary block with infiltration MCAN

EXPERIMENTAL

With the performance of the axillary blok, 2 ml of scandicaine will be placed around the medial cutaneous ante brachial nerve (MACN)

Procedure: axillary blockDrug: Scandicaine

Interventions

2 ml of scandicaine 1.5 % is deposited in an inplane technique around the medial antebrachial cutaneous nerve with a 22 G sonoplex needle as a surplus to an axillary block

axillary block with infiltration MCAN

2 ml of scandicaine 1.5 % is deposited in an inplane technique around the medial antebrachial cutaneous nerve with a 22 G sonoplex needle as a surplus to an axillary block

Also known as: mepivacaine
axillary block with infiltration MCAN

Eligibility Criteria

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

You may qualify if:

  • all patients scheduled for lower arm/hand surgery

You may not qualify if:

  • patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Antwerp

Antwerp, 2650, Belgium

Location

Related Publications (1)

  • Ranganath A, Srinivasan KK, Iohom G. Ultrasound guided axillary brachial plexus block. Med Ultrason. 2014 Sep;16(3):246-51. doi: 10.11152/mu.2013.2066.163.2kks.

    PMID: 25110766BACKGROUND

MeSH Terms

Interventions

Mepivacaine

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • margaretha breebaart

    Univeristy Hospital Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

October 30, 2014

First Posted

July 11, 2017

Study Start

September 1, 2014

Primary Completion

December 1, 2019

Study Completion

January 30, 2020

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations