Clinical trial NCT03290196: The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics
Official title: The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Rotator Cuff Tear
Keywords: Shoulder
Rotator cuff
Lead sponsor: Andrews Research & Education Foundation
Sponsor class: OTHER
Collaborators: name: Pacira Pharmaceuticals, Inc
First posted: 2017-09-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: VAS Pain Score
timeFrame: 12 hours, 24 hours, 36 hours, 48 hours
measure: Narcotic Medication Usage
timeFrame: 12 hours, 24 hours, 36 hours, 48 hours, 3 days, 7 days, 14 days
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons Shoulder Score (ASES) on Surgical Arm
timeFrame: 2 weeks
measure: American Shoulder and Elbow Surgeons Shoulder Score (ASES) of Healthy Arm
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: Andrews Research & Education Foundation
state: Florida
Study officials:
affiliation: Andrews Institute for Orthopaedics & Sports Medicine
name: James R Andrews, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson MD, Mickler T, Arthur GR, Rosenburg S, Wilson R. Bupivacaine with and without epinephrine for intercostal nerve block. J Cardiothorac Anesth. 1990 Apr;4(2):200-3. doi: 10.1016/0888-6296(90)90238-b.
citation: Colombo G, Padera R, Langer R, Kohane DS. Prolonged duration local anesthesia with lipid-protein-sugar particles containing bupivacaine and dexamethasone. J Biomed Mater Res A. 2005 Nov 1;75(2):458-64. doi: 10.1002/jbm.a.30443.
citation: Bergese SD, Onel E, Morren M, Morganroth J. Bupivacaine extended-release liposome injection exhibits a favorable cardiac safety profile. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):145-51. doi: 10.1097/AAP.0b013e31823d0a80.
citation: Portillo J, Kamar N, Melibary S, Quevedo E, Bergese S. Safety of liposome extended-release bupivacaine for postoperative pain control. Front Pharmacol. 2014 Apr 30;5:90. doi: 10.3389/fphar.2014.00090. eCollection 2014.
citation: Candiotti K. Liposomal bupivacaine: an innovative nonopioid local analgesic for the management of postsurgical pain. Pharmacotherapy. 2012 Sep;32(9 Suppl):19S-26S. doi: 10.1002/j.1875-9114.2012.01183.x.
citation: Cohen SM, Vogel JD, Marcet JE, Candiotti KA. Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis. J Pain Res. 2014 Jun 24;7:359-66. doi: 10.2147/JPR.S63764. eCollection 2014.
citation: Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4.
citation: Singelyn FJ, Lhotel L, Fabre B. Pain relief after arthroscopic shoulder surgery: a comparison of intraarticular analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg. 2004 Aug;99(2):589-92, table of contents. doi: 10.1213/01.ANE.0000125112.83117.49.
citation: Borgeat A, Ekatodramis G, Kalberer F, Benz C. Acute and nonacute complications associated with interscalene block and shoulder surgery: a prospective study. Anesthesiology. 2001 Oct;95(4):875-80. doi: 10.1097/00000542-200110000-00015.
citation: Fredrickson MJ, Kilfoyle DH. Neurological complication analysis of 1000 ultrasound guided peripheral nerve blocks for elective orthopaedic surgery: a prospective study. Anaesthesia. 2009 Aug;64(8):836-44. doi: 10.1111/j.1365-2044.2009.05938.x.
citation: Jeng CL, Torrillo TM, Rosenblatt MA. Complications of peripheral nerve blocks. Br J Anaesth. 2010 Dec;105 Suppl 1:i97-107. doi: 10.1093/bja/aeq273.