NCT03290196

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2022

Completed
3 years until next milestone

Results Posted

Study results publicly available

March 30, 2025

Completed
Last Updated

March 30, 2025

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

September 18, 2017

Results QC Date

January 30, 2023

Last Update Submit

March 18, 2025

Conditions

Rotator Cuff Tear

Keywords

ShoulderRotator cuff

Outcome Measures

Primary Outcomes (2)

  • VAS Pain Score

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

    12 hours, 24 hours, 36 hours, 48 hours

  • Narcotic Medication Usage

    Number of narcotic medication tablets consumed

    12 hours, 24 hours, 36 hours, 48 hours, 3 days, 7 days, 14 days

Secondary Outcomes (2)

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

    2 weeks

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

    2 weeks

Study Arms (1)

EXPAREL 1.3 % in 20 ML Injection

OTHER

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)

Drug: EXPAREL 1.3 % in 20 ML Injection

Interventions

EXPAREL 1.3 % in 20 ML InjectionDRUG

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

Also known as: bupivacaine liposome injectable suspension
EXPAREL 1.3 % in 20 ML Injection

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female
  • years of age
  • Subjects scheduled to undergo a rotator cuff repair with a subacromial decompression by one of the protocol investigators

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrews Research & Education Foundation

Gulf Breeze, Florida, 32561, United States

Location

Related Publications (11)

  • 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.

    PMID: 2131867BACKGROUND

  • 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.

    PMID: 16088895BACKGROUND

  • 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.

    PMID: 22266897BACKGROUND

  • 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.

    PMID: 24817851BACKGROUND

  • 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.

    PMID: 22956491BACKGROUND

  • 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.

    PMID: 25018650BACKGROUND

  • 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.

    PMID: 24793570BACKGROUND

  • 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.

    PMID: 15271745BACKGROUND

  • 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.

    PMID: 11605927BACKGROUND

  • 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.

    PMID: 19604186BACKGROUND

  • 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.

    PMID: 21148659BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Injections

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title
Jessica Truett
Organization
Andrews Research and Education Foundation
jessica.truett@andrewsref.org
8509168570

Study Officials

  • James R Andrews, MD

    Andrews Institute for Orthopaedics & Sports Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 21, 2017

Study Start

September 3, 2015

Primary Completion

December 22, 2016

Study Completion

April 7, 2022

Last Updated

March 30, 2025

Results First Posted

March 30, 2025

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)