Comparison of Central Versus Peripheral Placement of Local Anesthetic - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00699244

Purpose

Does ultrasound increases the success rate and if there is a difference in success rate between placing the local anesthetic centrally versus peripherally.

Condition	Intervention
Hand Surgery Elbow Surgery Forearm Surgery Wrist Surgery	Device: ultrasound

MedlinePlus related topics: Anesthesia Surgery Ultrasound

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Selective Local Anesthetic Placement Using Ultrasound-Guidance and Neurostimulation for the Infraclavicularbrachial Plexus Block

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

increase success rate of the block to produce surgical anesthesia and analgesia [ Time Frame: during and following surgical procedure ] [ Designated as safety issue: No ]

Estimated Enrollment:	218
Study Start Date:	December 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental to receive ultrasound guided peripheral placement of local anesthetic	Device: ultrasound ultrasound guided placement
2: No Intervention to receive central placement of local anesthetic

Detailed Description:

A comparison of the infraclavicular placement of local anesthetic either centrally (posterior cord) vs peripheral placement (lateral or medial cord) using ultrasound guidance. This will be done to determine if ultrasound increases the success rate and if there is a difference in success rate between placing the local anesthetic centrally versus peripherally.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) Class I-III.
Patient is undergoing elective hand or forearm surgery.
Patient is an adult, 18 years old or older.

Exclusion Criteria:

Morbid obesity (calculated body mass index > 35 kg/m2).
Patient unable to cooperate.
Patient with a known brachial plexus injury.
Medical contraindication to anesthetic technique (allergy, cardiac condition, neurologic condition, localized infection, bleeding disorder).
Patients who are pregnant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699244

Locations

United States, Tennessee
Vanderbilt University Orthopedic Surgicenter
Nashville, Tennessee, United States, 37212

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Clifford Bowens, M.D.

clifford.bowens@vanderbilt.edu

More Information

Additional Information:

Vanderbilt University Medical Center Department of Anesthesiology This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Vanderbilt University ( Clifford Bowens )
Study ID Numbers:	61267
Study First Received:	June 12, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00699244 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

forearm
hand
elbow

wrist
brachial plexus
infraclavicular block

Study placed in the following topic categories:

Central Nervous System Depressants
Anesthetics
Peripheral Nervous System Agents
Anesthetics, Local

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on May 07, 2009