Comparison of Central Versus Peripheral Placement of Local Anesthetic

June 9, 2017 updated by: Clifford Bowens, Vanderbilt University

Selective Local Anesthetic Placement Using Ultrasound-guidance and Neurostimulation for the Infraclavicularbrachial Plexus Block

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
increase success rate of the block to produce surgical anesthesia and analgesia
Time Frame: during and following surgical procedure
during and following surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Clifford Bowens, M.D., clifford.bowens@vanderbilt.edu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 12, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Actual)

June 12, 2017

Last Update Submitted That Met QC Criteria

June 9, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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