Ultrasound Guided Intercostobrachial Nerve Block

April 11, 2018 updated by: Dr. Christoph Ilies

Area of Sensory Loss, Onset Time and Duration of Two Different Ultrasound Guided Intercostobrachial Nerve Blocks for Vascular Access Surgery of the Upper Arm

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The participants will be randomized into two groups:

Group one receives a modified PECS 2 (thoracic wall) block above the second intercostal space with injection between the Musculus serratus anterior and Musculus pectoralis minor.

Group 2 receives a subpectoral block under the pectoralis major muscle at the medial boarder of the axillary triangle.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden Württemberg
      • Stuttgart, Baden Württemberg, Germany, 70199
        • Marienhospital Stuttgart, Dpt. of Anaesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anterior musculus serratus block

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%
Ultrasound guided nerve block
Other Names:
  • ropivacain Sintetica 0.5%
Active Comparator: Subpectoral block

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%
Ultrasound guided nerve block
Other Names:
  • ropivacain Sintetica 0.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blocked area in squared cm
Time Frame: Assessment 30 minutes after intervention
Area of sensory loss to pin prick test
Assessment 30 minutes after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Block onset time in minutes
Time Frame: Complete timeframe of 45 minutes with testing every 5 minutes
Onset time of complete analgesia. Assessment by pin prick test in the middle of the axilla
Complete timeframe of 45 minutes with testing every 5 minutes
Block duration in minutes
Time Frame: Assessment every 30 minutes for 8 hours after nerve block
Complete analgesia to pin prick in the middle of the axilla
Assessment every 30 minutes for 8 hours after nerve block
The pain numeric rating scale (NRS) during surgical manipulation in the axilla
Time Frame: From beginning to end of surgery. Estimated mean duration of 90 minutes.
From beginning to end of surgery. Estimated mean duration of 90 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Christoph Ilies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 11, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • iCobra 2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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