Ultrasound-guided Supraclavicular Brachial Plexus Blockade

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Manitoba.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00523055
First received: August 28, 2007
Last updated: April 25, 2011
Last verified: April 2011
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • brachial plexus block quality [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
  • Physiotherapy quality [ Time Frame: within 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2008
Estimated 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523055

Contacts
Contact: Eric N Sutherland, MD 2042849796 ericsuds@mts.net

Locations
Canada, Manitoba
Health Sciences Pain Management Centre Recruiting
Winnipeg, Manitoba, Canada, R3P1S4
Sub-Investigator: Craig Haberman, MD         
Sub-Investigator: Ryan Amadeo, MD         
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Eric N Sutherland, MD University of Manitoba
  More Information

Publications:
Responsible Party: Eric Sutherland, University of Manitoba
ClinicalTrials.gov Identifier: NCT00523055     History of Changes
Other Study ID Numbers: B2007:078
Study First Received: August 28, 2007
Last Updated: April 25, 2011
Health Authority: Canada: University of Manitoba Research Ethics Board

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 29, 2014