NCT02305875

Brief Summary

The investigators have made a favourable experience with the in 2006 published transarterial triple injection method \[4\]. This classic method combines the block effect of an axillary catheter injection (median nerve position) with a double transarterial injection at terminal nerve level in the axilla. The investigators experience after a recent published MRI study \[3\], confirms that a proximal axillary local anesthetic injection via an axillary catheter, guided by nerve stimulator, is beneficial for the block effect. The MRI study was conducted using nerve stimulation and a transarterial technique. The proximal injection with an effect at cord level, combined with axillary injections at terminal nerve level, produce an effective block distal to the elbow. The proximal injection has obviously an effect to the lateral cord and the musculocutaneous nerve (mcn) \[3\]. Recent studies have advocated that a double axillary injection method is sufficient for the axillary block \[5, 6\]. Their block techniques included a selective block of the mcn at terminal nerve level. The investigators MRI study \[3\] demonstrated a successful block effect (analgesia or anaesthesia) of the mcn nerve in all patients (15 of 15 patients) in the triple injection group without a selective block of this nerve. In the 1- deposit (catheter injection) and 2-deposit (transarterial injections) group, 11 of 15 patients (73%) had the mcn successful blocked. The objective in this study (Article 4) is to examine the mean position of the mcn nerve and its relationship to the coracobrachial muscle. Can MRI indicate / predict that a proximal directed axillary catheter in median nerve position is beneficial in order to provide a successful mcn blockade? Is a selective injection to the mcn at terminal nerve level superfluous when a catheter is used?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 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

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 18, 2015

Status Verified

May 1, 2015

Enrollment Period

6 months

First QC Date

November 19, 2014

Last Update Submit

May 15, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Position of the musculocutaneous nerve in the axillary sheat. Mean distance in cm to the humeral head and the insertion point of the catheter in 54 patients.

    6 months

Study Arms (1)

MCN scoring

EXPERIMENTAL

Scoring of the mcn nerve's position in the axillary sheat using MRI

Other: MCN scoring

Interventions

Mcn's distance from top of the humeral head. Mcn's distance to the catheters insertion point. Mcn's distance and position in relationship to the axillary artery.

MCN scoring

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for hand surgery
  • ASA 1 - 2
  • Weight from 50 - 95 kg
  • MR compatible, suitable

You may not qualify if:

  • Neurologic deficit
  • Reaction to LA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Intervention Centre, Rikshospitalet, Oslo University Hospital

Oslo, 0027, Norway

Location

Study Officials

  • Per Kr Hol, PhD

    University of Oslo, The Intervention Centre

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 19, 2014

First Posted

December 3, 2014

Study Start

October 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

May 18, 2015

Record last verified: 2015-05

Locations