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Ultrasound Guided Intercostobrachial Nerve Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805582
Recruitment Status : Completed
First Posted : June 20, 2016
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Christoph Ilies, Marienhospital Stuttgart

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.

Condition or disease Intervention/treatment Phase
Anaesthesia Drug: 10ml ropivacain 0.5% Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Area of Sensory Loss, Onset Time and Duration of Two Different Ultrasound Guided Intercostobrachial Nerve Blocks for Vascular Access Surgery of the Upper Arm
Actual Study Start Date : August 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: 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 Name: ropivacain Sintetica 0.5%




Primary Outcome Measures :
  1. Blocked area in squared cm [ Time Frame: Assessment 30 minutes after intervention ]
    Area of sensory loss to pin prick test


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805582


Locations
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Germany
Marienhospital Stuttgart, Dpt. of Anaesthesiology
Stuttgart, Baden Württemberg, Germany, 70199
Sponsors and Collaborators
Dr. Christoph Ilies
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Responsible Party: Dr. Christoph Ilies, Dr. med., Marienhospital Stuttgart
ClinicalTrials.gov Identifier: NCT02805582    
Other Study ID Numbers: iCobra 2016
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Christoph Ilies, Marienhospital Stuttgart:
Peripheral Nerve Block