The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics

March 18, 2025 updated by: Andrews Research & Education Foundation
Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of this study. The purpose of this study is to determine if the product EXPAREL® can be used as a safe alternative in shoulder surgery to pain pumps, while limiting narcotic use and providing appropriate postoperative pain control.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Based on prior research, it is hypothesized EXPAREL® can potentially be used as a local anesthetic option after undergoing an arthroscopic rotator cuff repair in the outpatient setting. Conducting this study, will allow the option for a surgeon to administer a local anesthetic, in a single injection, to the exact location of the surgical procedure and in a sterile environment. The purpose of this pilot study is to determine if EXPAREL® can be used as a safe alternative to current post-operative pain control methods, while limiting narcotic use and providing appropriate postoperative analgesia.

Study Type

Interventional

Enrollment (Actual)

13

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
    • Florida
      • Gulf Breeze, Florida, United States, 32561
        • Andrews Research & Education 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

14 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female
  • 18-72 years of age
  • Subjects scheduled to undergo a rotator cuff repair with a subacromial decompression by one of the protocol investigators

Exclusion Criteria:

  • Planned concomitant glenoid labral repair
  • Previous open shoulder surgery
  • Neurological deficit or other disability involving the surgical extremity
  • Anyone with a documented allergy to bupivicaine
  • Subjects that are not mentally competent to give consent
  • Pregnant women
  • Subjects with an intolerance to hydrocodone or oxycodone and/or brand name equivalent combination medication

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EXPAREL 1.3 % in 20 ML Injection

EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% [13.3 mg/mL]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:

  • size of surgical site
  • volume required to cover the area
  • individual patient factors that may impact the safety of an amide local anesthetic
  • maximum doe of 266 mg (20 mL)
Drug: EXPAREL 1.3 % in 20 ML Injection
EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.
Other Names:
  • bupivacaine liposome injectable suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS Pain Score
Time Frame: 12 hours, 24 hours, 36 hours, 48 hours
Patient reported numeric pain rating using visual analog scale (VAS) (0 = none, 10 = severe)
12 hours, 24 hours, 36 hours, 48 hours
Narcotic Medication Usage
Time Frame: 12 hours, 24 hours, 36 hours, 48 hours, 3 days, 7 days, 14 days
Number of narcotic medication tablets consumed
12 hours, 24 hours, 36 hours, 48 hours, 3 days, 7 days, 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Shoulder and Elbow Surgeons Shoulder Score (ASES) on Surgical Arm
Time Frame: 2 weeks
American Shoulder and Elbow Surgeons Shoulder Score (ASES) of surgical arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function)
2 weeks
American Shoulder and Elbow Surgeons Shoulder Score (ASES) of Healthy Arm
Time Frame: 2 weeks
American Shoulder and Elbow Surgeons Shoulder Score (ASES) of healthy (nonsurgical) arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function)
2 weeks

Collaborators and Investigators

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

Sponsor

Andrews Research & Education Foundation

Collaborators

Pacira Pharmaceuticals, Inc

Investigators

  • Principal Investigator: James R Andrews, MD, Andrews Institute for Orthopaedics & Sports Medicine

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)

September 3, 2015

Primary Completion (Actual)

December 22, 2016

Study Completion (Actual)

April 7, 2022

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (Actual)

September 21, 2017

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EXPAREL

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

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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