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

Phase 4

Terminated

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
EXPAREL 1.3 % in 20 ML Injection	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)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
American Shoulder and Elbow Surgeons Shoulder Score (ASES) on Surgical Arm	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)
American Shoulder and Elbow Surgeons Shoulder Score (ASES) of Healthy Arm	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)