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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02805582
Other study ID # iCobra 2016
Secondary ID
Status Completed
Phase N/A
First received April 28, 2016
Last updated April 11, 2018
Start date August 2016
Est. completion date February 2018

Study information

Verified date April 2018
Source Marienhospital Stuttgart
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date February 2018
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
10ml ropivacain 0.5%
Ultrasound guided nerve block

Locations

Country Name City State
Germany Marienhospital Stuttgart, Dpt. of Anaesthesiology Stuttgart Baden Württemberg

Sponsors (1)

Lead Sponsor Collaborator
Dr. Christoph Ilies

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blocked area in squared cm Area of sensory loss to pin prick test Assessment 30 minutes after intervention
Secondary Block onset time in 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
Secondary Block duration in minutes Complete analgesia to pin prick in the middle of the axilla Assessment every 30 minutes for 8 hours after nerve block
Secondary The pain numeric rating scale (NRS) during surgical manipulation in the axilla From beginning to end of surgery. Estimated mean duration of 90 minutes.
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