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

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ClinicalTrials.gov Identifier: NCT03290196
Recruitment Status : Active, not recruiting
First Posted : September 21, 2017
Last Update Posted : February 21, 2018
Sponsor:
Collaborator:
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
Andrews Research & Education Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Drug: EXPAREL 1.3 % in 20 ML Injection Phase 4

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics
Actual Study Start Date : September 3, 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
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 Name: bupivacaine liposome injectable suspension




Primary Outcome Measures :
  1. Daily Log of Pain Score [ Time Frame: 2 weeks ]
    Daily reported patient numeric pain rating

  2. Daily Log of Narcotic Medication Usage [ Time Frame: 2 weeks ]
    Number of narcotic medication consumed


Secondary Outcome Measures :
  1. American Shoulder and Elbow Surgeons Shoulder Score (ASES) [ Time Frame: 2 week follow-up visit ]
    Pain score measured utilizing patient questionnaire answers

  2. American Shoulder and Elbow Surgeons Shoulder Score (ASES) [ Time Frame: 2 week follow-up visit ]
    Function score measured utilizing patient questionnaire answers



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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290196


Locations
United States, Florida
Andrews Research & Education Foundation
Gulf Breeze, Florida, United States, 32561
Sponsors and Collaborators
Andrews Research & Education Foundation
Pacira Pharmaceuticals, Inc
Investigators
Principal Investigator: James R Andrews, MD Andrews Institute for Orthopaedics & Sports Medicine

Publications:

Responsible Party: Andrews Research & Education Foundation
ClinicalTrials.gov Identifier: NCT03290196     History of Changes
Other Study ID Numbers: EXPAREL
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Andrews Research & Education Foundation:
Shoulder
Rotator cuff

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Bupivacaine
Narcotics
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics