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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03290196
• Other study ID #: EXPAREL
• Status: Suspended
• Phase: Phase 4
• Start date: September 3, 2015
• Est. completion date: July 2022

Study information

• Verified date: March 2020
• Source: Andrews Research & Education Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: July 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 72 Years

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Drug:
• EXPAREL 1.3 % in 20 ML Injection
EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.

Locations

Country	Name	City	State
United States	Andrews Research & Education Foundation	Gulf Breeze	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Andrews Research & Education Foundation	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Log of Pain Score	Daily reported patient numeric pain rating	2 weeks
Primary	Daily Log of Narcotic Medication Usage	Number of narcotic medication consumed	2 weeks
Secondary	American Shoulder and Elbow Surgeons Shoulder Score (ASES)	Pain score measured utilizing patient questionnaire answers	2 week follow-up visit
Secondary	American Shoulder and Elbow Surgeons Shoulder Score (ASES)	Function score measured utilizing patient questionnaire answers	2 week follow-up visit