Comparison of Central Versus Peripheral Placement of Local Anesthetic

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clifford Bowens, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00699244
First received: June 12, 2008
Last updated: February 4, 2013
Last verified: September 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Selective Local Anesthetic Placement Using Ultrasound-guidance and Neurostimulation for the Infraclavicularbrachial Plexus Block

Resource links provided by NLM:


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 ]

Enrollment: 218
Study Start Date: December 2006
Study Completion Date: March 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
to receive ultrasound guided peripheral placement of local anesthetic
Device: ultrasound
ultrasound guided placement
No Intervention: 2
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
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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:
No publications provided

Responsible Party: Clifford Bowens, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00699244     History of Changes
Other Study ID Numbers: 61267
Study First Received: June 12, 2008
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
forearm
hand
elbow
wrist
brachial plexus
infraclavicular block

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on October 19, 2014