Liposomal Bupivacaine in Ambulatory Hand Surgery

August 5, 2019 updated by: Subhas Gupta, MD, PhD, Loma Linda University

This study is being done to evaluate pain management regimens following ambulatory hand surgery. Improved pain control may be associated with decreased complications, decreased pain scores, decreased opioid dependence, improved patient comfort and satisfaction, and reduced healthcare costs. Liposomal bupivacaine is an FDA-approved local anesthetic. There will be two groups. One group will receive liposomal bupivacaine. One group will not. The results will be compared.

Patients will be over the age of 18 ambulatory hand surgery. Approximately 40 subjects will participate in this study at LLU.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

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
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University

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 and over undergoing ambulatory hand surgery involving soft tissue and subfascial structures, including: CMC arthritis, flexor and extensor tendon injury, symptomatic ganglia, hand and finger fractures

Exclusion Criteria:

  • Patients who are unable to give informed consent to participate in this study
  • Patients with a documented history of hypersensitivity reactions to local anesthetic agents
  • Patients with a diagnosis of chronic pain disorders such as fibromyalgia, chronic migraine headaches, or psychiatric disorders other than depression or anxiety
  • Patients who are currently pregnant
  • Patients with impaired hepatic function
  • Patients with underlying nerve damage or impairment
  • Patients with renal impairment/failure
  • Patients whose career/livelihood require a great deal of hand dexterity, in whom a complication could cause a significant impact on life and career (ex: musician, dentist)

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
No Intervention: Control Group
Patients in Group 1 (Plain Bupivacaine) will be treated intra-operatively with injections of 0.25% bupivacaine, with 10 mL (25 mg) delivered to perform a field block of the soft tissue and subfascial plane at the initiation of the surgical procedure.
Experimental: Experimental Group
Patients in Group 2 (Liposomal Bupivacaine + Plain Bupivacaine) will be treated intra-operatively with the initial injection of 0.25% bupivacaine 5 - 10 mL (12.5 - 25 mg) delivered to perform a field block of the soft tissue and subfascial plane at the initiation of the procedure.
Drug: Liposomal Bupivicaine
Patients in Group 2 (Liposomal Bupivacaine + Plain Bupivacaine) will be treated intra-operatively with the initial injection of 0.25% bupivacaine 5 - 10 mL (12.5 - 25 mg) delivered to perform a field block of the soft tissue and subfascial plane at the initiation of the procedure.
Other Names:
  • Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Opioid Use
Time Frame: At scheduled intervals up to 168 hours post-operatively
Patients will record their opioid use post-operatively
At scheduled intervals up to 168 hours post-operatively

Collaborators and Investigators

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

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Subhas Gupta, MD, Chair of the Department of Plastic Surgery

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 (Anticipated)

February 9, 2018

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5150445

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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