Liposomal Bupivacaine for Pain Control After Rotator Cuff Repair

September 30, 2018 updated by: Paul Sethi, Orthopaedic & Neurosurgery Specialists

Liposomal Bupivacaine Reduces Opiate Consumption After Rotator Cuff Repair in a Randomized Control Trial

The use of an interscalene block (ISB) is often associated with rebound pain that could be avoided through adjunctive therapy with longer duration. Administration of a liposomal bupivacaine (LB) field block in addition to ISB would overcome this rebound pain to provide greater pain relief and reduce opiate consumption when compared to ISB alone. 50 patients were recruited and randomized into groups that either received or did not receive an intraoperative LB field block in addition to standard ISB administration. Visual Analog Scale (VAS) pain scores and narcotic consumption were recorded over the five-day postoperative period to determine the effectiveness of LB pain relief.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Arthroscopic rotator cuff repair (ARCR) provides excellent clinical outcomes but is often associated with significant postoperative pain. As rotator cuff repair procedures become increasingly more common, these procedures and the narcotic prescriptions which accompany them may contribute to the rising opioid epidemic. The use of intraoperative local and regional anesthesia or field blocks, in conjunction with multimodal pharmacological strategies, is a widely accepted approach for managing surgical pain and reducing opiate use. The purpose of this study was to determine whether using a field block of liposomal bupivacaine (LB) in addition to an interscalene block (ISB) would provide greater pain relief and reduction in opiate consumption when compared to ISB alone.

The study enrolled 50 patients undergoing primary ARCR surgery. Patients were randomized to receiving intraoperative liposomal bupivacaine or not and provided with postoperative "Pain Journals" to document their daily pain on a visual analog scale (VAS) and to track their daily opioid consumption during the first five post-operative days.

Study Type

Interventional

Enrollment (Actual)

50

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
    • Connecticut
      • Greenwich, Connecticut, United States, 06831
        • Orthopaedic & Neurosurgery Specialists

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least 18 years of age
  • undergoing an arthroscopic rotator cuff repair surgery of a full thickness tear
  • willing to fill out the "Pain Journal"; able to understand the informed consent process
  • willing to document informed consent prior to completion of any study-related procedure
  • able to read, comprehend, and complete subject-reported outcome measures in English

Exclusion Criteria:

  • pregnant
  • documented history of drug or alcohol abuse
  • use of narcotic painkillers greater than 3 months prior to surgery
  • neurologic deficit or disability involving the surgical extremity
  • known allergy or intolerance to hydrocodone or oxycodone
  • known allergy to amide anesthetics
  • currently enrolled or planning to enroll in another clinical trial during this study that would affect the outcome of this study
  • history of cognitive or mental health status that interferes with study participation

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liposomal Bupivacaine (LB)
Administration of 20 ml of LB diluted with an additional 40 ml of saline was injected into a triangular soft tissue surgical field block, along with standard bupivacaine interscalene block
Drug: Liposomal bupivacaine (LB)
Addition of LB solution to soft tissue surgical field block to a standard interscalene block procedure
Other Names:
  • EXPAREL
No Intervention: Interscalene Block Alone (ISB)
Administration of 20mL of 0.5% standard bupivacaine interscalene block with no additional soft tissue surgical field block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Opioid Consumption in Oral Morphine Equivalent
Time Frame: Post-operative day one to five
Total amount of narcotics consumed over the study period following surgery
Post-operative day one to five

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale Pain Scores
Time Frame: Post-operative day one to five
A standardized measure of subjective pain on a scale of 0 to 10, from zero pain to excruciating pain, respectively
Post-operative day one to five

Collaborators and Investigators

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

Sponsor

Orthopaedic & Neurosurgery Specialists

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 30, 2018

First Posted (Actual)

October 2, 2018

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 30, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016017

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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