Who is sponsoring NCT03636542?

NCT03636542 is sponsored by University of Minnesota.

What drugs are being tested in NCT03636542?

Interventions in NCT03636542: liposomal bupivacaine, bupivacaine.

What condition does NCT03636542 study?

NCT03636542 studies Phrenic Nerve Paralysis.

Is NCT03636542 still recruiting?

NCT03636542 is currently completed. Last updated 30 November 2022.

Are results published for NCT03636542?

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

Last reviewed 2022-11-30 · How we verify

NCT03636542

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

Evaluation of Diaphragm Movement After an Interscalene Block

Completed Phase 4 Results posted Last updated 30 November 2022

What this trial tests

Phase 4 trial testing liposomal bupivacaine in Phrenic Nerve Paralysis in 26 participants. Completed in 3 June 2020.

Timeline

1 August 2018

Primary endpoint
3 June 2020

3 June 2020

Quick facts

Lead sponsor	University of Minnesota
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	screening
Enrollment	26
Start date	1 August 2018
Primary completion	3 June 2020
Estimated completion	3 June 2020
Sites	1 location across United States

Drugs / interventions tested

liposomal bupivacaine — full drug profile →
bupivacaine (BUPIVACAINE) — full drug profile →

Conditions studied

Phrenic Nerve Paralysis — all drugs for Phrenic Nerve Paralysis →

Sponsor

University of Minnesota

Who can join

18 and older, any sex, with Phrenic Nerve Paralysis. 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.

Diaphragm Excursion With Sigh Primary · change from baseline to 24 hours after block

Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position.

Group	Value	95% CI
Liposomal Bupivacaine	4.2	1.6 – 5.0
Bupivacaine	2.9	1.7 – 3.5

Diaphragm Excursion With Quick Inspiratory Breath Secondary · change from baseline to 24 hours after block

Evaluation of diaphragm excursion (movement in cm) from rest to a quick inspiratory breath.

Group	Value	95% CI
Liposomal Bupivacaine	1.8	1.3 – 2.9
Bupivacaine	1.2	0.7 – 2.3

Forced Expiratory Volume in 1 Second (FEV1) Secondary · change from baseline to 24 hours after block

Evaluation of FEV1 via spirometry.

Group	Value	95% CI
Liposomal Bupivacaine	2.7	1.9 – 3.2
Bupivacaine	1.8	1.7 – 2.1

Forced Vital Capacity (FVC) Secondary · change from baseline to 24 hours after block

Evaluation of FVC via spirometry.

Group	Value	95% CI
Liposomal Bupivacaine	3.2	2.3 – 3.5
Bupivacaine	2.0	1.8 – 2.3

FEV1/FVC Secondary · change from baseline to 24 hours after block

Evaluation of FEV1/FVC percent via spirometry.

Group	Value	95% CI
Liposomal Bupivacaine	86	86.2 – 97.3
Bupivacaine	89.5	82.3 – 93.0

Sponsor's own description

The purpose of this study is to evaluate the movement of the diaphragm after an interscalene block with liposome bupivacaine (LB) compared to interscalene block (IB) with bupivacaine. This study will evaluate if there is a possible prolonged phrenic nerve paralysis when using liposome bupivacaine in an interscalene block, using ultrasound.

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 trials of liposomal bupivacaine

Trials testing the same drug.

NCT06557018 — Efficacy and Safety of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty · Phase 4 · recruiting
NCT03587584 — Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair · Phase 4 · completed
NCT03599635 — Pec Infiltration With Liposomal Bupivacaine for Breast Surgery · Phase 4 · completed

Other University of Minnesota trials

Trials by the same sponsor.

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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 NCT03636542 (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: 30 November 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/NCT03636542.

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