Study of A Long Lasting Local Anesthestic for Hand, Wrist or Finger Surgery

May 15, 2024 updated by: Jose Soberon, MD

Exparel (Bupivacaine Liposome Injectable Suspension) for Distal Upper Extremity Blocks in Orthopedic Surgery

The purpose of this study is to compare Exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 4

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

Yes

Description

Inclusion Criteria:

  • patients 18 years or older having hand, wrist, or finger surgery
  • ability to understand and provide informed consent
  • American Society of Anesthesiologists status I-III
  • presence of a responsible adult caregiver for 48-72 hours after surgery

Exclusion Criteria:

  • patient refusal or inability to provide informed consent
  • true allergy, not sensitivity to local anesthetics, midazolam, fentanyl, hydromorphone, propofol
  • pregnancy
  • hepatic or renal failure
  • evidence of infection at or near the proposed needle insertion site
  • any sensorimotor deficit of the upper extremity
  • BMI greater than or equal to 35
  • uncontrolled or severe pulmonary disease
  • anticoagulant use (not aspirin or non-steroidal anti-inflammatories)
  • chronic pain patients

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bupivacaine supraclavicular block
Under ultrasound guidance, 20-30 mL 0.5% Bupivacaine will be used for the supraclavicular block.
Drug: Bupivacaine supraclavicular block
20-30mL 0.5% bupivacaine
Experimental: Exparel forearm block
Under ultrasound guidance, 3-5 milliliters (mL) Exparel will be injected around the 3 nerves of the forearm prior to surgery. 20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
Drug: Exparel Forearm block
20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
Other Names:
  • bupivacaine liposome injectable suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Onset of Sensorimotor Block
Time Frame: 30 minutes
A blinded study staff member will evaluate the subject after the block is performed. Subjects will be asked to move their hand and will be asked if they can feel a sharp sensation on specific areas of their hand. Once no movement and no feeling is detected, the block is considered successful and the time will be noted.
30 minutes

Collaborators and Investigators

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

Sponsor

Jose Soberon, MD

Collaborators

Pacira Pharmaceuticals, Inc

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

February 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 6, 2014

First Submitted That Met QC Criteria

February 6, 2014

First Posted (Estimated)

February 10, 2014

Study Record Updates

Last Update Posted (Actual)

May 21, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04262013

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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