NCT02805582

Brief Summary

The intercostobrachial nerve underlies many anatomical variations. For surgery of the upper arm the axilla is usually not anaesthetized by a brachial plexus block, which therefore needs to be completed by an intercostobrachial nerve block. The optimal access for an ultrasound guided block of the intercostobrachial nerve is not yet known. The investigators compare a proximal and a more distal approach to the nerve referred to onset time, sensory blocked area and duration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

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

First Submitted

Initial submission to the registry

April 28, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

April 12, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

April 28, 2016

Last Update Submit

April 11, 2018

Conditions

Anaesthesia

Keywords

Peripheral Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Blocked area in squared cm

    Area of sensory loss to pin prick test

    Assessment 30 minutes after intervention

Secondary Outcomes (3)

  • Block onset time in minutes

    Complete timeframe of 45 minutes with testing every 5 minutes

  • Block duration in minutes

    Assessment every 30 minutes for 8 hours after nerve block

  • The pain numeric rating scale (NRS) during surgical manipulation in the axilla

    From beginning to end of surgery. Estimated mean duration of 90 minutes.

Study Arms (2)

Anterior musculus serratus block

ACTIVE COMPARATOR

Proximal nerve block above the second intercostal space between Musculus serratus anterior and Musculus pectoralis minor. Intervention: 10ml ropivacain 0.5%

Drug: 10ml ropivacain 0.5%

Subpectoral block

ACTIVE COMPARATOR

Distal nerve block under the Musculus pectoralis major at the medial border of the axillary triangle. Intervention: 10ml ropivacain 0.5%

Drug: 10ml ropivacain 0.5%

Interventions

10ml ropivacain 0.5%DRUG

Ultrasound guided nerve block

Also known as: ropivacain Sintetica 0.5%
Anterior musculus serratus blockSubpectoral block

Eligibility Criteria

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

You may qualify if:

  • patients planned for vascular access surgery of the upper arm
  • surgery planned under regional anaesthesia

You may not qualify if:

  • patients refusal
  • age under 18
  • allergy against local anaesthetics
  • polyneuropathies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marienhospital Stuttgart, Dpt. of Anaesthesiology

Stuttgart, Baden-Wurttemberg, 70199, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

April 28, 2016

First Posted

June 20, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2017

Study Completion

February 1, 2018

Last Updated

April 12, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)