NCT03587584: RCR

Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair

Completed Phase 4 Results posted Last updated 27 July 2022

What this trial tests

Phase 4 trial testing liposomal bupivacaine in Acute Pain in 80 participants. Completed in 8 June 2021.

Timeline

25 July 2018

Primary endpoint
25 May 2021

8 June 2021

Quick facts

Lead sponsor	University of Minnesota
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	80
Start date	25 July 2018
Primary completion	25 May 2021
Estimated completion	8 June 2021
Sites	1 location across United States

Drugs / interventions tested

• liposomal 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 Intraoperative Opioids Used Primary · through end of surgery

Total amount of opioid medications used during surgery. Opioids normalized to total morphine equivalents.

Intraoperative Fentanyl (mg)

Group	Value	95% CI
Liposomal Bupivacaine	.1	.1 – .1
Bupivacaine	.1	.05 – .1

Intraoperative MME (mg)

Group	Value	95% CI
Liposomal Bupivacaine	30	30 – 30
Bupivacaine	30	15 – 30

Intraoperative hydromorphone (mg)

Group	Value	95% CI
Liposomal Bupivacaine	0	0 – 0
Bupivacaine	0	0 – 0

Intraoperative ketamine

Group	Value	95% CI
Liposomal Bupivacaine	0	0 – 0
Bupivacaine	0	0 – 0

Intraoperative ketorolac (mg)

Group	Value	95% CI
Liposomal Bupivacaine	0	0 – 30
Bupivacaine	0	0 – 30

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.

Liposomal Bupivacaine

Serious: 0/33 (0%)

Deaths: 0/33

Bupivacaine

Serious: 0/33 (0%)

Deaths: 0/33

Other adverse events (2 terms — click to expand)

Reaction	System	Liposomal Bupivacaine	Bupivacaine
Nausea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT03587584 adverse events section.

Sponsor's own description

The purpose of this study is to compare pain control after arthroscopic rotator cuff repair surgery using either liposomal bupivacaine or bupivacaine when injected in an interscalene block. Both medications, liposomal bupivacaine and bupivacaine, are standard of care in these types of surgeries.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparing liposomal bupivacaine plus bupivacaine to bupivacaine alone in interscalene blocks for rotator cuff repair surgery: a randomized clinical trial.
   Flaherty JM, Berg AA, Harrison A, Braman J, et al · · 2022 · cited 18× · PMID 35190468 · DOI 10.1136/rapm-2021-103349