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Ultrasound-guided Supraclavicular Brachial Plexus Blockade

This study has been terminated.
(Clinical volume of patients for recruitment stopped.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00523055
First Posted: August 30, 2007
Last Update Posted: May 10, 2017
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.
Information provided by (Responsible Party):
University of Manitoba
  Purpose
Pain Clinic patients undergoing physiotherapy for rehabilitation often have arm freezing performed. The quality of physiotherapy is felt to be superior with good pain control. The quality of the freezing is felt to be better when it is done with ultrasound guidance. We are able to use less drug to achieve the same result. For this reason, we are doing a study to look at the level of freezing drug that accumulates in the body. We feel that the drug levels will be significantly different. We also feel that the time-to-peak drug level will be different than with traditional arm freezing procedures.

Condition Intervention
Pain Drug: Lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Ultrasound-guided Supraclavicular Brachial Plexus Blockade: A Pharmacokinetic Study of Lidocaine and Adrenaline

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Lidocaine drug level [ Time Frame: 40 minutes ]

Secondary Outcome Measures:
  • brachial plexus block quality [ Time Frame: 30 minutes ]
  • Physiotherapy quality [ Time Frame: within 2 hours ]

Enrollment: 10
Study Start Date: May 2008
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lidocaine
    Lidocaine, 5 mg/kg, via needle placed adjacent to brachial plexus with ultrasound, dosing separated by 1 week, 2 doses in total, one block will contain 5 mcg/kg of adrenaline
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • patients undergoing brachial plexus anesthesia as part of disease management who have consented to participate in the study

Exclusion Criteria:

  • Contraindication to brachial plexus anesthesia
  • Informed consent not obtained
  Contacts and Locations
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): NCT00523055


Locations
Canada, Manitoba
Health Sciences Pain Management Centre
Winnipeg, Manitoba, Canada, R3P1S4
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Eric N Sutherland, MD University of Manitoba
  More Information

Publications:
Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT00523055     History of Changes
Other Study ID Numbers: B2007:078
First Submitted: August 28, 2007
First Posted: August 30, 2007
Last Update Posted: May 10, 2017
Last Verified: April 2011

Keywords provided by University of Manitoba:
Pain
Brachial Plexus Anesthesia
Plasma Lidocaine Levels
Ultrasound

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action