- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00523055
Ultrasound-guided Supraclavicular Brachial Plexus Blockade
May 9, 2017 updated by: University of Manitoba
Ultrasound-guided Supraclavicular Brachial Plexus Blockade: A Pharmacokinetic Study of Lidocaine and Adrenaline
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3P1S4
- Health Sciences Pain Management Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lidocaine drug level
Time Frame: 40 minutes
|
40 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
brachial plexus block quality
Time Frame: 30 minutes
|
30 minutes
|
Physiotherapy quality
Time Frame: within 2 hours
|
within 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric N Sutherland, MD, University of Manitoba
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Neal JM, Hebl JR, Gerancher JC, Hogan QH. Brachial plexus anesthesia: essentials of our current understanding. Reg Anesth Pain Med. 2002 Jul-Aug;27(4):402-28. doi: 10.1053/rapm.2002.34377. No abstract available. Erratum In: Reg Anesth Pain Med 2002 Nov-Dec;27(6):625.
- Norder H, Hammas B, Larsen J, Skaug K, Magnius LO. Detection of HBV DNA by PCR in serum from an HBsAg negative blood donor implicated in cases of post-transfusion hepatitis B. Arch Virol Suppl. 1992;4:116-8. doi: 10.1007/978-3-7091-5633-9_24.
- Soares LG, Brull R, Lai J, Chan VW. Eight ball, corner pocket: the optimal needle position for ultrasound-guided supraclavicular block. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):94-5. doi: 10.1016/j.rapm.2006.10.007. No abstract available.
- Beach ML, Sites BD, Gallagher JD. Use of a nerve stimulator does not improve the efficacy of ultrasound-guided supraclavicular nerve blocks. J Clin Anesth. 2006 Dec;18(8):580-4. doi: 10.1016/j.jclinane.2006.03.017.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
August 28, 2007
First Submitted That Met QC Criteria
August 28, 2007
First Posted (Estimate)
August 30, 2007
Study Record Updates
Last Update Posted (Actual)
May 10, 2017
Last Update Submitted That Met QC Criteria
May 9, 2017
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- B2007:078
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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