Efficacy of Interscalene Brachial Plexus Block With Liposomal Bupivacaine for Arthroscopic Shoulder Surgery

Condition(s) targeted: Shoulder Pain; Rotator Cuff Tear

Intervention: Liposomal bupivacaine (Drug); Bupivacaine 0.25% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: St. Luke's-Roosevelt Hospital Center

Official(s) and/or principal investigator(s):
Ali Shariat, MD, Principal Investigator, Affiliation: St. Luke's-Roosevelt Hospital Center

The purpose of this study is to compare the quality and duration of pain relief after shoulder surgery provided by a single injection of liposomal bupivacaine versus standard bupivacaine when administered as an interscalene brachial plexus block. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.

Official title: Comparison of Cumulative Opioid Consumption After Interscalene Brachial Plexus Block With Liposomal Bupivacaine (Exparel; 88 mg in 20 cc) Versus Bupivacaine 0.25% for Arthroscopic Shoulder Surgery

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Total opioid consumption

Secondary outcome:

Quality of analgesia

Onset and duration of sensory block

Time to first pain medicine

Time to discharge home

Incidence of postoperative nausea and vomiting

Minimum age: 17 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- English speaking adults (age >17 years) of American Society of Anesthesiologists

(ASA) I-III physical class scheduled for elective arthroscopic shoulder surgery will be eligible to participate regardless of race/ethnicity. Exclusion Criteria:

- Subjects will not be eligible for this trial if they report a history of an allergy

to a local anesthetic, baseline neurological deficit, a medical condition that would make it difficult to assess sensory distribution or communicate with the staff, a recent history (< 3 months) of drug or alcohol abuse, concomitant opioid therapy, or a preexisting coagulation disorder.

St. Luke's Roosevelt Hospital Center, New York, New York 10025, United States

Starting date: January 2014
Last updated: June 2, 2015