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Rotator Cuff TearPhase 4NCT03290196

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

A Phase 4 study testing EXPAREL 1.3 % in 20 ML Injection in people with Rotator Cuff Tear, run by Andrews Research & Education Foundation at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 72 years
Conditions the study is for
Rotator Cuff Tear
What is being tested?
EXPAREL 1.3 % in 20 ML Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteUnited States
Study dates
3 Sep 2015to 7 Apr 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 72 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Andrews Research & Education Foundation

    Gulf Breeze, Florida, 32561

Other trials in United States

About this study

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.

Read the 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.

Being tested
EXPAREL 1.3 % in 20 ML Injection
Keywords
Shoulder, Rotator cuff
Medical subject headings
Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EXPAREL 1.3 % in 20 ML InjectionDrug

    Also called bupivacaine liposome injectable suspension

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

Study groups in NCT03290196
Study groupRoleWhat they receive
EXPAREL 1.3 % in 20 ML InjectionOtherEXPAREL (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)
Receives: Drug: EXPAREL 1.3 % in 20 ML Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VAS Pain Score

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

    Measured: 12 hours, 24 hours, 36 hours, 48 hours

  2. Narcotic Medication Usage

    Number of narcotic medication tablets consumed

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

Secondary outcomes (2)

  1. 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)

    Measured: 2 weeks

  2. 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)

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2017
  2. Study start3 Sep 2015
  3. Primary completion22 Dec 2016
  4. Study completion7 Apr 2022

Why it stopped: Patients pain was not regulated well with this product.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03290196
Sponsor's protocol ID
EXPAREL
Status last verified
Apr 2024
First submitted
18 Sep 2017
Last updated
30 Mar 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 2131867

  • 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.

    PubMed 16088895

  • 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.

    PubMed 22266897

  • 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.

    PubMed 24817851

  • 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.

    PubMed 22956491

  • 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.

    PubMed 25018650

  • 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.

    PubMed 24793570

  • 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.

    PubMed 15271745

  • 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.

    PubMed 11605927

  • 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.

    PubMed 19604186

  • 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.

    PubMed 21148659

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing EXPAREL 1.3 % in 20 ML Injection in people with Rotator Cuff Tear, run by Andrews Research & Education Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS Pain Score (time frame: 12 hours, 24 hours, 36 hours, 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03290196, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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