Liposomal Bupivacaine in Rotator Cuff Repair

May 6, 2024 updated by: Amit Momaya, University of Alabama at Birmingham

Efficacy of Liposomal Bupivacaine in Arthroscopic Rotator Cuff Repair

To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

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
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • UAB Hospital-Highlands

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Undergoing outpatient arthroscopic rotator cuff repair
  • Greater than or equal to 19 years of age at the time of surgery

Exclusion Criteria:

  • Planned operative fixation of the biceps tendon or acromioclavicular joint
  • Opioid use 6 weeks before surgery
  • Gabapentin use 6 weeks before surgery
  • History of prior shoulder surgery on the operative limb
  • Severe pulmonary dysfunction
  • Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s)
  • History of radicular pain or neuropathy in the operative limb
  • Patients who are currently incapacitated for medical decision making

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: Liposomal bupivacaine Interscalene Block

Interscalene block:

  • 10cc (133mg) liposomal bupivacaine;PLUS
  • 10cc 0.25% bupivacaine
Drug: Exparel
A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
Other Names:
  • liposomal bupivacaine
Active Comparator: Ropivacaine Interscalene Catheter
  • 20cc 0.25% bupivacaine interscalene block; PLUS
  • Ropivacaine 0.25% interscalene catheter (6ml/hr for 48hrs)
Drug: Ropivacaine
A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Postoperative Pain Scores Over a 96 Hour Timeframe
Time Frame: Up to 96 hrs postoperative
Visual analog pain scores after operation [0-10, with 10 being the worst pain]
Up to 96 hrs postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe
Time Frame: Up to 96 hrs
oral morphine equivalents of all opioid-containing medications received
Up to 96 hrs
Average Analgesia Satisfaction Over a 96 Hour Timeframe
Time Frame: Up to 96 hrs
Likert scale of analgesia satisfaction [0-5, with 5 being the most satisfied]
Up to 96 hrs
Percentage of Participants With Analgesia Complications
Time Frame: Up to 96 hrs
Complications resulting from the method of analgesia utilized
Up to 96 hrs
Average Sleep Quality Over a 96 Hour Timeframe
Time Frame: Up to 96 hrs postoperative
Scale of sleep quality [0-10, with 10 being the most satisfied]
Up to 96 hrs postoperative
Average Hours of Painless Sleep
Time Frame: Up to 96 hrs postoperative
Hours of sleep uninterrupted by pain [numerical, hours]
Up to 96 hrs postoperative

Collaborators and Investigators

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

Sponsor

University of Alabama at Birmingham

Collaborators

Pacira Pharmaceuticals, Inc

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)

December 15, 2019

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (Actual)

November 13, 2018

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300002544

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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