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Comparison of Central Versus Peripheral Placement of Local Anesthetic

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ClinicalTrials.gov Identifier: NCT00699244
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Clifford Bowens, Vanderbilt University

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

Condition or disease Intervention/treatment Phase
Hand Surgery Elbow Surgery Forearm Surgery Wrist Surgery Procedure: Peripheral placement of local anesthesia Procedure: Central placement of local anesthesia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Selective Local Anesthetic Placement Using Ultrasound-guidance and Neurostimulation for the Infraclavicularbrachial Plexus Block
Study Start Date : December 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
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




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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699244


Locations
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United States, Tennessee
Vanderbilt University Orthopedic Surgicenter
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Clifford Bowens, M.D. clifford.bowens@vanderbilt.edu
Additional Information:
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Responsible Party: Clifford Bowens, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00699244    
Other Study ID Numbers: 61267
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Clifford Bowens, Vanderbilt University:
forearm
hand
elbow
wrist
brachial plexus
infraclavicular block
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs