Trial | NCT03290196  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Suspended

  • Study Participants

    60
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.
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 Started
Sep 03
2015
Primary Completion
Jan 31
2022
Anticipated
Study Completion
Jul 31
2022
Anticipated
Last Update
Mar 06
2020

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

EXPAREL 1.3 % in 20 ML Injection Other

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)

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
No Results Posted