Comparing Two Injection Sites of Local Anesthetic for Hand Surgery

March 21, 2016 updated by: Jose Soberon, MD

A Comparison Of Distal Peripheral Nerve Blockade Versus Traditional Proximal Approaches For Hand Surgery

The purpose of this study is to compare two different injection sites for local anesthesia in patients having hand surgery. The hypothesis is that subjects receiving injections around the three nerves of the forearm will provide faster pain control and greater patient satisfaction than patients having one injection closer to the shoulder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation

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:

  • Patients ≥ 18 years of age undergoing unilateral hand, wrist, or finger surgery
  • Ability to understand and provide informed consent
  • American Society of Anesthesiologists (ASA) status I-III

Exclusion Criteria:

  • Patient refusal or inability to provide informed consent
  • True allergy, not sensitivity, to any of the following substances: Local Anesthetics, Midazolam, Fentanyl, Hydromorphone, Propofol
  • Pregnancy
  • Severe hepatic impairment
  • Evidence of infection at or near the proposed needle insertion site
  • Any sensorimotor deficit of the ipsilateral upper extremity, whether acute or chronic, as determined by the PI and designee
  • Pulmonary disease of any kind that is uncontrolled or severe in nature
  • Chronic pain patients, defined as someone diagnosed with chronic pain or a chronic pain condition, under the care of a chronic pain physician, or taking oral/intravenous narcotics consistently for 30 days prior to surgery

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: distal injection
0.5% bupivacaine injected in the forearm
Procedure: 0.5% bupivacaine injected in the forearm
Median, Ulnar, and Radial nerve blocks performed in the forearm
Active Comparator: proximal injection
20-30ml of 0.5% bupivacaine
Procedure: 20-30ml of 0.5% bupivacaine.
supraclavicular, infraclavicular, or axillary nerve block using 20-30ml of 0.5% bupivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
success of block
Time Frame: up to 30 minutes after injection
number of participants that needed additional anesthesia
up to 30 minutes after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain scores
Time Frame: up to 10 days after surgery
change in pain scores
up to 10 days after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to complete injection
Time Frame: up to 30 minutes
difference between the end of injection time and the beginning
up to 30 minutes

Collaborators and Investigators

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

Sponsor

Jose Soberon, MD

Investigators

  • Principal Investigator: Jose Soberon, MD, Ochsner Health System

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

April 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 8, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soberon Forearm

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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