NCT03587636 is a Phase 2 clinical trial of liposome bupivacaine in Acute Pain, sponsored by University of Minnesota.

Who is sponsoring NCT03587636?

NCT03587636 is sponsored by University of Minnesota.

What drugs are being tested in NCT03587636?

Interventions in NCT03587636: liposome bupivacaine, Bupivacaine.

What condition does NCT03587636 study?

NCT03587636 studies Acute Pain.

Is NCT03587636 still recruiting?

NCT03587636 is currently completed. Last updated 2 May 2022.

Are results published for NCT03587636?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-05-02 · How we verify

NCT03587636

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Liposome Bupivacaine Interscalene Total Shoulder

Completed Phase 2 Results posted Last updated 2 May 2022

What this trial tests

Phase 2 trial testing liposome bupivacaine in Acute Pain in 77 participants. Completed in 17 March 2021.

Timeline

17 September 2018

Primary endpoint
15 March 2021

17 March 2021

Quick facts

Lead sponsor	University of Minnesota
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	77
Start date	17 September 2018
Primary completion	15 March 2021
Estimated completion	17 March 2021
Sites	1 location across United States

Drugs / interventions tested

liposome bupivacaine — full drug profile →
Bupivacaine (BUPIVACAINE) — full drug profile →

Conditions studied

Acute Pain — all drugs for Acute Pain →

Sponsor

University of Minnesota

Who can join

18 and older, any sex, with Acute Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Opioid Use Primary · From end of surgery through 72 hours after end of surgery

total amount of opioid use from after surgery through 72 hours. Opioids normalized to morphine equivalents

Group	Value	95% CI
Bupivacaine Interscalene Block	22.5	7.5 – 96.0
Liposome Bupivacaine Interscalene Block	30.0	5.6 – 45.0

Total Maximum Pain Scores f Secondary · time from end of surgery through 72 hours after end of surgery

Sum total of maximal pain scores through 72 horus after surgery. Pain scores reported on a numerical rating scale from 0-10. 10 is worse and 0 is best

Group	Value	95% CI
Bupivacaine Interscalene Block	4.0	2.0 – 6.0
Liposome Bupivacaine Interscalene Block	3.0	1.0 – 5.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 72 hours. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Bupivacaine Interscalene Block

Serious: 0/37 (0%)

Deaths: 0/37

Liposome Bupivacaine Interscalene Block

Serious: 0/33 (0%)

Deaths: 0/33

Other adverse events (5 terms — click to expand)

Reaction	System	Bupivacaine Interscalene B…	Liposome Bupivacaine Inter…
Fall weeks after surgery	Ear and labyrinth disorders	—	—
Bruising/ swelling	Blood and lymphatic system disorders	—	—
Balance Issues weeks after surgery	Ear and labyrinth disorders	—	—
Numbness/ swelling	Nervous system disorders	—	—
Appendicitis several weeks after surgery	Infections and infestations	—	—

Data from ClinicalTrials.gov NCT03587636 adverse events section.

Sponsor's own description

This is a randomized prospective outcomes study comparing two groups of patients. One group will receive liposomal bupivacaine plus bupivacaine and the other will receive bupivacaine alone in interscalene blocks when undergoing total shoulder arthroplasty. The purpose of the study is to determine if LB plus bupivacaine provides superior pain control compared to bupivacaine alone when injected in an interscalene block for patients undergoing total shoulder arthroplasty surgery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Acute Pain

Currently open trials in the same condition.

NCT06779604 — Dexmedetomidine and Dexamethasone Added as Adjuvant Infraclavicular Brachial Plexus Block in Upper Limb Surgery · recruiting
NCT07348419 — Quadro-Iliac vs Thoracolumbar Interfascial Plane Block for Analgesia After Single-Level Lumbar Disc Surgery · NA · recruiting
NCT07335159 — Does Patient Testimonial Improve the Pain Relief Derived From a Brief Intervention · NA · recruiting
NCT07348523 — Comparison of the Postoperative Analgesic Efficacy of Classical and Modified Erector Spinae Plane Blocks After Lumbar Sp · NA · recruiting
NCT07336264 — Characterization of Acute Pain · recruiting

Other University of Minnesota trials

Trials by the same sponsor.

NCT02421497 — MRI Technical Development and Applications in Kidney Disease · not yet recruiting
NCT04100109 — Evaluating the Metabolic Effects of Polylactose: A Novel Prebiotic · NA · withdrawn
NCT05454306 — Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures · NA · withdrawn
NCT03192007 — Multi-Parametric MRI for Renal Transplantation · not yet recruiting
NCT04940533 — Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03587636 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Minnesota
Last refreshed: 2 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03587636.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing