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Minimum Effective Volume of Lidocaine Costoclavicular Brachial Plexus 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: NCT02932670
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
De Tran, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
The aim of this study is to determine the minimum effective volume of lidocaine in 90% of patients (ED90) required for single-injection US-guided costoclavicular infraclavicular.

Condition or disease Intervention/treatment Phase
Upper Extremity Surgery Other: costoclavicular nerve block Not Applicable

Detailed Description:
The aim of this study is to determine the minimum effective volume of lidocaine in 90% of patients (ED90) required for single-injection US-guided costoclavicular ICB. Determination of the minimum effective volume of LA is important because it prevents the administration of an unnecessarily large (and potentially toxic) dose. Furthermore, when multiple blocks need to be performed at the same time in the same patient, knowledge of the minimum effective volume allows to the operator to preserve efficacy without sacrificing safety for each block.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minimum Effective Volume of Lidocaine for Ultrasound-Guided Costoclavicular Infraclavicular Brachial Plexus Block
Study Start Date : October 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Active Comparator: costoclavicular inflaclavicular block
costoclavicular block with similar volume
Other: costoclavicular nerve block
ultrasound-guided costoclavicular nerve block

Experimental: costoclavicular block
costoclavicular block with decreasing volume
Other: costoclavicular nerve block
ultrasound-guided costoclavicular nerve block




Primary Outcome Measures :
  1. success rate [ Time Frame: 0-30 min ]
    minimal composite score of 14 out of 16



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 and 70 years
  • American Society of Anesthesiologists classification 1-3
  • body mass index between 20 and 30

Exclusion Criteria:

  • adults who are unable to give their own consent
  • pre-existing neuropathy (assessed by history and physical examination)
  • coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
  • renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine≥ 100)
  • hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases≥ 100)
  • allergy to local anesthetics
  • pregnancy
  • prior surgery in the infraclavicular region
  • chronic pain syndromes requiring opioid intake at home

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): NCT02932670


Locations
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Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G-1A4
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: De QH Tran, MD McGill University Health Centre/Research Institute of the McGill University Health Centre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: De Tran, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT02932670    
Other Study ID Numbers: Montreal General Hospital
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No