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

Andrews Research & Education Foundation

Status and phase: Terminated; Phase 4

Conditions: Rotator Cuff Tear

Treatments: Drug: EXPAREL 1.3 % in 20 ML Injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03290196

EXPAREL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

EXPAREL 1.3 % in 20 ML Injection

Other group

Description:

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)

Treatment:

Drug: EXPAREL 1.3 % in 20 ML Injection