NCT03682224: BEMP

Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients

Completed Phase 3 Results posted Last updated 12 January 2023

What this trial tests

Phase 3 trial testing Liposomal Bupivacaine in Non Small Cell Lung Cancer in 57 participants. Completed in 3 September 2022.

Timeline

5 July 2018

Primary endpoint
3 September 2022

3 September 2022

Quick facts

Lead sponsor	Southern Illinois University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	57
Start date	5 July 2018
Primary completion	3 September 2022
Estimated completion	3 September 2022
Sites	1 location across United States

Drugs / interventions tested

• Liposomal Bupivacaine — full drug profile →
• Bupivacaine-Epinephrine — full drug profile →

Conditions studied

• Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
• Lung Cancer Stage 1 — all drugs for Lung Cancer Stage 1 →

Sponsor

Southern Illinois University

Who can join

Adults 18 to 80, any sex, with Non Small Cell Lung Cancer or Lung Cancer Stage 1. 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 Morphine Equivalents Consumed Primary · up to 72 hours post surgery

Measured as overall intake of any drugs in the opioid class (Morphine Equivalent Dosing)

Group	Value	95% CI
Exparel	48	23 – 71
Marcaine	42.7	28.4 – 55.5

VAS Pain Score Secondary · In-hospital until discharge, approximately 3 days, will be collected each time before dispensing pain medications

Using a 10 point visual analog scale (VAS) score. The score ranges from 0 to 10. '0' represents no pain and '10' represents worst pain.

Group	Value	95% CI
Exparel	4.8	4.3 – 6.2
Marcaine	5.2	4.2 – 6.6

Treatment Cost Secondary · In-hospital Costs until discharge, approximately 3 days

All direct cost from the date of surgery until discharge

Group	Value	95% CI
Exparel	22,775	19,930 – 30,659
Marcaine	20,252	18,225 – 25,521

Pharmacy Cost Secondary · In-hospital until discharge, approximately 3 days

Median In-hospital pharmacy cost

Group	Value	95% CI
Exparel	1052	970 – 1295
Marcaine	596	497 – 738

Mortality Secondary · Up to 30 days post surgery

Any death occurring during primary hospital stay or prior to 30 days post surgery

Group	Value	95% CI
Exparel	0
Marcaine	0

Hospital Stay Secondary · Length of hospital stay - from admission to discharge, approximately 3 days

Group	Value	95% CI
Exparel	3.28	2.16 – 4.27
Marcaine	2.45	2.08 – 3.45

Pneumothorax Secondary · In-hospital until discharge, approximately 3 days

Documented pnuemothorax

Group	Value	95% CI
Exparel	5
Marcaine	6

Prolonged Air Leak Secondary · > 5 days to 7 days

Number of patients who had air leak more than 5 days post-surgery

Group	Value	95% CI
Exparel	8
Marcaine	5

Atrial Fibrillation/Other Arrhythmia Secondary · In-hospital until discharge, approximately 3 days

Post-op arrhythmia

Group	Value	95% CI
Exparel	2
Marcaine	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 30 days post surgery. Reporting threshold: 4%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Exparel

Serious: 12/26 (46%)

Deaths: 0/26

Marcaine

Serious: 9/24 (38%)

Deaths: 0/24

Serious adverse events (4 terms)

Reaction	System	Exparel	Marcaine
Prolonged air leak	Respiratory, thoracic and mediastinal disorders	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—
Atrial Fibrillation/Other Arrhythmia	Cardiac disorders	—	—
Infection	Infections and infestations	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Exparel	Marcaine
Acute Renal Failure	Renal and urinary disorders	—	—
Ileus	Gastrointestinal disorders	—	—

Most-reported serious reactions: Prolonged air leak, Pneumothorax, Atrial Fibrillation/Other Arrhythmia, Infection.

Data from ClinicalTrials.gov NCT03682224 adverse events section.

Sponsor's own description

The purpose of this study is to assess pain management after elective thoracoscopic lobectomy. The study will compare two local anesthetics that are given intra-operatively during lobectomy to see which one helps in better pain control and to see which one helps decrease the need for opioid medications. Participants will receive either Marcaine (Bupivacaine-epinephrine 0.25%, 1:200,000) or Exparel (Bupivacaine liposomal (1.3%)) and the drug will be chosen in a random fashion. Participants will be followed during the hospital stay and for one year thereafter. An visual Scale will be administered to measure pain, and opioid drug use will be measured by calculating morphine equivalent dose on each day post surgery until discharge and thereafter on 30 day, 6 month and 12 month follow-up visits. Participants will be monitored for any drug related toxicity and other co-morbid conditions for a period on one year post surgery. Overall cost for the surgery and during in hospital stay post surgery will be collected and compared between the two treatment arms.

Publications & conference data

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

1. Current advances in the use of exosomes, liposomes, and bioengineered hybrid nanovesicles in cancer detection and therapy.
   Mukherjee A, Bisht B, Dutta S, Paul MK. · · 2022 · cited 88× · PMID 35379933 · DOI 10.1038/s41401-022-00902-w