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Infraclavicular or Supraclavicular Brachial Plexus Blocks for Elbow Surgery

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ClinicalTrials.gov Identifier: NCT02677506
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Shalini Dhir, Lawson Health Research Institute

Brief Summary:
This study compares the infraclavicular approach to supraclavicular approach of brachial plexus block for elbow surgery.

Condition or disease Intervention/treatment Phase
Cubital Tunnel Syndrome Biceps Tendon Rupture Procedure: Supraclavicular Procedure: Infraclavicular Not Applicable

Detailed Description:

Traditionally, infraclavicular as well as supraclavicular approaches to brachial plexus have been recommended for elbow surgery. Supraclavicular approach is considered to have a more rapid onset. However, investigators have noticed that the supraclavicular approach needs more supplementation if it is used for elbow surgery. Therefore more and more anesthesiologists now choose the infraclavicular approach for elbow surgery (though both approaches are recommended in the text books).

None of the published studies have addressed if one approach is indeed superior to the other specifically for elbow surgery. Therefore the investigators propose to undertake a study that will evaluate the two approaches to the brachial plexus specifically for elbow surgery.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Infraclavicular and Supraclavicular Brachial Plexus Blocks for Elbow Surgery
Study Start Date : January 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016


Arm Intervention/treatment
Experimental: Supraclavicular
Supraclavicular brachial plexus block will be done.
Procedure: Supraclavicular
Brachial plexus block with supraclavicular approach

Active Comparator: Infraclavicular
Infraclavicular brachial plexus block block will be done.
Procedure: Infraclavicular
Brachial plexus block with infraclavicular approach




Primary Outcome Measures :
  1. Time to completion of block [ Time Frame: 30 minutes ]
    A clock will be used to assess this outcome. Complete sensory block in all dermatomes will be tested with ice.


Secondary Outcome Measures :
  1. Readiness for surgery [ Time Frame: 60 minutes ]
    A clock will be used to assess this outcome. Complete sensory and motor block at the time of incision will be considered readiness of surgery.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for ambulatory elbow surgery under block
  • ASA 1-3

Exclusion Criteria:

  • Narcotic dependent
  • Severe systemic illness
  • Refusal of block
  • localized infection

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): NCT02677506


Locations
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Canada, Ontario
St. Joseph's Hospital
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Shalini Dhir, FRCPC Western University

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Responsible Party: Shalini Dhir, Associate Scientist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02677506     History of Changes
Other Study ID Numbers: 101723
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Shalini Dhir, Lawson Health Research Institute:
elbow
Additional relevant MeSH terms:
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Ulnar Nerve Compression Syndromes
Nerve Compression Syndromes
Cubital Tunnel Syndrome
Rupture
Wounds and Injuries
Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains