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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: June 9, 2017
Last verified: June 2017
  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 Procedure: Peripheral placement of local anesthesia Procedure: Central placement of local anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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 Clifford Bowens, Vanderbilt University:

Primary Outcome Measures:
  • increase success rate of the block to produce surgical anesthesia and analgesia [ Time Frame: during and following surgical procedure ]

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: Peripheral placement of local anesthesia
to receive ultrasound guided peripheral placement of local anesthetic
Procedure: Peripheral placement of local anesthesia
Peripheral placement of local anesthesia
Active Comparator: Central placement of local anesthesia
to receive central placement of local anesthetic
Procedure: Central placement of local anesthesia
Central placement of local anesthesia

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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: 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:
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: June 9, 2017
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 27, 2017