Effectiveness of Ultrasound (US) Guided Supraclavicular Block

January 19, 2017 updated by: Jaime Ortiz, Baylor College of Medicine

Effectiveness of Ultrasound Guided Supraclavicular Brachial Plexus Block With 20, 30, or 40 ml of Ropivacaine 0.5%

This research study is being done in order to find out if there is any difference in the effectiveness of ultrasound guided supraclavicular brachial plexus nerve block that can be achieved with 3 different amounts of ropivacaine 0.5% (20 ml, 30 ml, and 40 ml). The investigators want to show if you can have a successful nerve block with less amount of local anesthetic, thus potentially decreasing the risk of side effects.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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
    • Texas
      • Houston, Texas, United States, 77030
        • Ben Taub General Hospital

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 to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between the ages of 18-64,
  • Patients who are ASA I-III, presenting for distal upper extremity surgery. Surgeries to be considered are ORIF of distal upper extremity fractures such as ORIF radius, ORIF ulna, ORIF of any bones in the wrist or hand, and distal upper extremity surgery involving bones or tendons for which postoperative pain is to be expected. No emergency surgeries will be considered.

Exclusion Criteria:

  • Emergency surgery,
  • Patient or surgeon refusal
  • Patients for which peripheral nerve block or study medications are contraindicated,
  • Patients on chronic analgesic therapy at home,
  • History of nerve injury, neuropathy, or known neurologic injury or illness, or inability to properly describe postoperative pain to investigators (language barrier, psychiatric disorder, dementia).

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group R20
Patient will receive 20 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
Drug: 20 ml of ropivacaine 0.5%
Patient will receive 20 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
Active Comparator: Group R30
Patient will receive 30 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
Drug: 30 ml of ropivacaine 0.5%
Patient will receive 30 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
Active Comparator: Group R40
Patient will receive 40 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.
Drug: 40 ml of ropivacaine 0.5%
Patient will receive 40 ml of ropivacaine 0.5% for their ultrasound guided supraclavicular block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Onset of analgesia
Time Frame: First 30 minutes
First 30 minutes
Duration of analgesia
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Total analgesic use
Time Frame: First 24 hours
First 24 hours

Collaborators and Investigators

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

Sponsor

Baylor College of Medicine

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 (Actual)

May 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (Estimate)

June 18, 2009

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24506

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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