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

History of Changes

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:

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

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:

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

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:

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. Review. 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.

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. 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.

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 May 22, 2013

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