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

Phase 4TerminatedNCT03290196

Andrews Research & Education Foundation13 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rotator Cuff Tear

Interventions

EXPAREL 1.3 % in 20 ML InjectionDRUG

EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 72 Years

Medical Language ↔ Plain English

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

Locations (1)

Andrews Research & Education Foundation

Gulf Breeze, Florida, United States

Outcomes

Primary Outcomes

VAS Pain Score

Patient reported numeric pain rating using visual analog scale (VAS) (0 = none, 10 = severe)

Time frame: 12 hours, 24 hours, 36 hours, 48 hours

Narcotic Medication Usage

Number of narcotic medication tablets consumed

Time frame: 12 hours, 24 hours, 36 hours, 48 hours, 3 days, 7 days, 14 days

Secondary Outcomes

American Shoulder and Elbow Surgeons Shoulder Score (ASES) on Surgical Arm

American Shoulder and Elbow Surgeons Shoulder Score (ASES) of surgical arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function)

Time frame: 2 weeks

American Shoulder and Elbow Surgeons Shoulder Score (ASES) of Healthy Arm

American Shoulder and Elbow Surgeons Shoulder Score (ASES) of healthy (nonsurgical) arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function)

Time frame: 2 weeks

Data from ClinicalTrials.gov

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