Shoulder PainPhase 4NCT03913091

Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)

A Phase 4 study testing Liposomal Bupivacaine and 0.5% Bupivacaine HCL in people with Shoulder Pain, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Shoulder Pain
What is being tested?: Liposomal Bupivacaine and 0.5% Bupivacaine HCL
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2019to 19 Jan 2021
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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients undergoing total shoulder arthroplasty;
Patients who consent to be randomized.

Who cannot join

Patients younger than 18 and older than 75;
Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
Patients who are allergic to oxycodone;
Patients who are unable to speak English;
Patients with diagnosed or self---reported cognitive dysfunction;
Patients with a history of neurologic disorder that can interfere with pain sensation;

Show all 13Show fewer

Patients with a history of drug or recorded alcohol abuse;
Patients who are unable to understand or follow instructions;
Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
Patients with BMI over 40;
Any patient that the investigators feel cannot comply with all study related procedures;
NYU Langone Health students, residents, faculty or staff members

Trial locations and contacts

1 site in 1 country.

United States1 site

NYU Langone Health
New York, New York, 10016

Other trials in United States

About this study

This is a phase IV , randomized, single-blind, single-center study comparing patient related outcomes such as postoperative pain and opioid usage for patients who receive ISB 's containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine HCL undergoing total shoulder arthroplasty. The objective of this study is to compare opioid utilization and pain management of patients who receive Exparel in an ISB vs standard 0.5% bupivacaine HCL during the initial 72 --- hour post --- operative period. Additionally, to understand the duration of block after addition of Exparel® to bupivacaine in an Interscalene block after TSA.

Conditions: Shoulder Pain
Being tested: Liposomal Bupivacaine, 0.5% Bupivacaine HCL
Keywords: Total Shoulder Arthroplasty (TSA), Interscalene Nerve Block (ISB)
Medical subject headings: Shoulder Pain

What participants receive

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

Liposomal BupivacaineDrug
Also called Exparel
Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
0.5% Bupivacaine HCLDrug
0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)

Study groups in NCT03913091
Study group	Role	What they receive
20 mL 0.5% Bupivacaine HCL	Experimental	Not described Receives: Drug: 0.5% Bupivacaine HCL
Interscalene nerve block with Liposomal + Bupivacaine 0.5%	Experimental	Administered in an Interscalene block for TSA Receives: Drug: Liposomal Bupivacaine

What is being measured

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

Opioid Utilization
Measure in morphine milligram equivalents [MME]
Measured: 24-72 hour, Post-Operative Period

Secondary outcomes (3)

Opioid Utilization
Measure in morphine milligram equivalents [MME]
Measured: Day 4-7, Post-Operative Period
Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale
PROMIS Pain Intensity surveys are made up of three pain intensity questions, on a scale of 1-5.
1. = No pain
2. = Mild
3. = Moderate
4. = Severe
5. = Very Severe
Measured: Day 1-7, Post-Operative Period
T-Scores, PROMIS Pain Intensity Scale
PROMIS Pain Intensity surveys are made up of three pain questions, which generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.
Measured: Day 1-7, Post-Operative Period

Timeline

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

1 Mar 201919 Jan 2021

First posted12 Apr 2019
Study start1 Mar 2019
Primary completion19 Jan 2021
Study completion19 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Shoulder PainStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03913091
Sponsor's protocol ID: 18-01183
Status last verified: Jan 2022
First submitted: 10 Apr 2019
Last updated: 1 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Data will be available to achieve aims in the approved proposal.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain

All Shoulder Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)
ClinicalTrials.gov ID: NCT03913091
Acronym / sponsor ID: 18-01183
Conditions: Shoulder Pain
Keywords: Total Shoulder Arthroplasty (TSA), Interscalene Nerve Block (ISB)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: 1 Mar 2019 (actual)
Primary completion: 19 Jan 2021 (actual)
Study completion: 19 Jan 2021 (actual)
First posted: 12 Apr 2019 (actual)
Results: Posted 1 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
20 mL 0.5% Bupivacaine HCL	Experimental	Drug: 0.5% Bupivacaine HCL
Interscalene nerve block with Liposomal + Bupivacaine 0.5%	Experimental	Drug: Liposomal BupivacaineAdministered in an Interscalene block for TSA

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients undergoing total shoulder arthroplasty;
Patients who consent to be randomized.

Key exclusion criteria (13 listed)

Patients younger than 18 and older than 75;
Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
Patients who are allergic to oxycodone;
Patients who are unable to speak English;
Patients with diagnosed or self---reported cognitive dysfunction;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Liposomal BupivacaineAlso: ExparelLiposomal Bupivacaine Plus 0.5% Bupivacaine HCL	Drug	Interscalene nerve block with Liposomal + Bupivacaine 0.5%
0.5% Bupivacaine HCL0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)	Drug	20 mL 0.5% Bupivacaine HCL

Primary outcome

Opioid Utilization
Time frame: 24-72 hour, Post-Operative Period
Measure in morphine milligram equivalents [MME]

3 secondary outcomes

Opioid Utilization
Time frame: Day 4-7, Post-Operative Period
Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale
Time frame: Day 1-7, Post-Operative Period
T-Scores, PROMIS Pain Intensity Scale
Time frame: Day 1-7, Post-Operative Period

Results and safety

Results posted to the registry on 1 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
20 mL 0.5% Bupivacaine HCL	92	72
Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%	92	78

Primary outcome: Opioid Utilization

Time frame: 24-72 hour, Post-Operative Period. Mean (Standard Deviation). Unit: Morphine Milligram Equivalents (MME)

Measure	20 mL 0.5% Bupivacaine HCL n = 72	Interscalene Nerve Block With Liposomal + Bupivacaine 0.5% n = 78
Value	54.79 (15.26)	30.38 (11.62)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
20 mL 0.5% Bupivacaine HCL	0 of 72 (0%)	2 of 72 (2.8%)	0 of 72
Interscalene Nerve Block With Liposomal + Bupivacaine 0.5%	0 of 78 (0%)	5 of 78 (6.4%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Data will be available to achieve aims in the approved proposal.

Related trials for Shoulder Pain

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Uchenna Umeh, MD principal investigator

New York Langone Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liposomal Bupivacaine and 0.5% Bupivacaine HCL in people with Shoulder Pain, run by NYU Langone Health 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 2 inclusion and 13 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: finished, as of the sponsor's last update on 1 Feb 2022. 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 1 Feb 2022). 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?

Opioid Utilization (time frame: 24-72 hour, Post-Operative Period). 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 NCT03913091.

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 1 Feb 2022.