Trial Outcomes & Findings for Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients (NCT NCT03682224)

NCT ID: NCT03682224

Last Updated: 2023-01-12

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 57 participants
• Primary outcome timeframe: up to 72 hours post surgery
• Results posted on: 2023-01-12

Participant Flow

Participant milestones

Measure	Exparel Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site	Marcaine Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Overall Study STARTED	29	28
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients

Baseline characteristics by cohort

Measure	Exparel n=26 Participants Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site	Marcaine n=24 Participants Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site	Total n=50 Participants Total of all reporting groups
Age, Continuous	65.6 years STANDARD_DEVIATION 7.6 • n=5 Participants	66.5 years STANDARD_DEVIATION 7.7 • n=7 Participants	66 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Comorbidities Hypertension	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Comorbidities Obesity	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Comorbidities Diabetes Mellitus	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Comorbidities COPD	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Comorbidities Asthma	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Comorbidities Arthritis	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Comorbidities GERD	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Comorbidities Hyperlipidemia	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 72 hours post surgery

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

Outcome measures

Measure	Exparel n=26 Participants Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site	Marcaine n=24 Participants Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Total Morphine Equivalents Consumed	48 MEq Interval 23.0 to 71.0	42.7 MEq Interval 28.4 to 55.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Exparel n=26 Participants Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site	Marcaine n=24 Participants Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
VAS Pain Score	4.8 score on a scale Interval 4.3 to 6.2	5.2 score on a scale Interval 4.2 to 6.6

SECONDARY outcome

Timeframe: In-hospital Costs until discharge, approximately 3 days

All direct cost from the date of surgery until discharge

Outcome measures

Measure	Exparel n=26 Participants Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site	Marcaine n=24 Participants Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Treatment Cost	22,775 United States Dollars	20,252 United States Dollars

SECONDARY outcome

Timeframe: In-hospital until discharge, approximately 3 days

Median In-hospital pharmacy cost

Outcome measures

Measure	Exparel n=26 Participants Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site	Marcaine n=24 Participants Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Pharmacy Cost	1052 United States Dollars Interval 970.0 to 1295.0	596 United States Dollars Interval 497.0 to 738.0

SECONDARY outcome

Timeframe: Up to 30 days post surgery

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

Outcome measures

Measure	Exparel n=26 Participants Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site	Marcaine n=24 Participants Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Mortality	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Length of hospital stay - from admission to discharge, approximately 3 days

Outcome measures

Measure	Exparel n=26 Participants Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site	Marcaine n=24 Participants Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Hospital Stay	3.28 Days Interval 2.16 to 4.27	2.45 Days Interval 2.08 to 3.45

OTHER_PRE_SPECIFIED outcome

Timeframe: In-hospital until discharge, approximately 3 days

Documented pnuemothorax

Outcome measures

Measure	Exparel n=26 Participants Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site	Marcaine n=24 Participants Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Pneumothorax	5 Participants	6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: > 5 days to 7 days

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

Outcome measures

Measure	Exparel n=26 Participants Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site	Marcaine n=24 Participants Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Prolonged Air Leak	8 Participants	5 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: In-hospital until discharge, approximately 3 days

Post-op arrhythmia

Outcome measures

Measure	Exparel n=26 Participants Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site	Marcaine n=24 Participants Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Atrial Fibrillation/Other Arrhythmia	2 Participants	3 Participants

Adverse Events

Exparel

Serious events: 12 serious events

Other events: 2 other events

Deaths: 0 deaths

Marcaine

Serious events: 9 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Exparel n=26 participants at risk Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site	Marcaine n=24 participants at risk Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Respiratory, thoracic and mediastinal disorders Prolonged air leak	30.8% 8/26 • Up to 30 days post surgery Follow-up period for all-cause mortality was 30 days. Any air-lead \>5 days to 7 days was documented as Prolonged air leak Follow-up period for all other adverse events was in-hospital until discharge, approximately 30 days.	20.8% 5/24 • Up to 30 days post surgery Follow-up period for all-cause mortality was 30 days. Any air-lead \>5 days to 7 days was documented as Prolonged air leak Follow-up period for all other adverse events was in-hospital until discharge, approximately 30 days.
Cardiac disorders Atrial Fibrillation/Other Arrhythmia	7.7% 2/26 • Up to 30 days post surgery Follow-up period for all-cause mortality was 30 days. Any air-lead \>5 days to 7 days was documented as Prolonged air leak Follow-up period for all other adverse events was in-hospital until discharge, approximately 30 days.	12.5% 3/24 • Up to 30 days post surgery Follow-up period for all-cause mortality was 30 days. Any air-lead \>5 days to 7 days was documented as Prolonged air leak Follow-up period for all other adverse events was in-hospital until discharge, approximately 30 days.
Infections and infestations Infection	7.7% 2/26 • Up to 30 days post surgery Follow-up period for all-cause mortality was 30 days. Any air-lead \>5 days to 7 days was documented as Prolonged air leak Follow-up period for all other adverse events was in-hospital until discharge, approximately 30 days.	0.00% 0/24 • Up to 30 days post surgery Follow-up period for all-cause mortality was 30 days. Any air-lead \>5 days to 7 days was documented as Prolonged air leak Follow-up period for all other adverse events was in-hospital until discharge, approximately 30 days.
Respiratory, thoracic and mediastinal disorders Pneumothorax	19.2% 5/26 • Up to 30 days post surgery Follow-up period for all-cause mortality was 30 days. Any air-lead \>5 days to 7 days was documented as Prolonged air leak Follow-up period for all other adverse events was in-hospital until discharge, approximately 30 days.	25.0% 6/24 • Up to 30 days post surgery Follow-up period for all-cause mortality was 30 days. Any air-lead \>5 days to 7 days was documented as Prolonged air leak Follow-up period for all other adverse events was in-hospital until discharge, approximately 30 days.

Other adverse events

Measure	Exparel n=26 participants at risk Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site	Marcaine n=24 participants at risk Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Renal and urinary disorders Acute Renal Failure	3.8% 1/26 • Up to 30 days post surgery Follow-up period for all-cause mortality was 30 days. Any air-lead \>5 days to 7 days was documented as Prolonged air leak Follow-up period for all other adverse events was in-hospital until discharge, approximately 30 days.	4.2% 1/24 • Up to 30 days post surgery Follow-up period for all-cause mortality was 30 days. Any air-lead \>5 days to 7 days was documented as Prolonged air leak Follow-up period for all other adverse events was in-hospital until discharge, approximately 30 days.
Gastrointestinal disorders Ileus	3.8% 1/26 • Up to 30 days post surgery Follow-up period for all-cause mortality was 30 days. Any air-lead \>5 days to 7 days was documented as Prolonged air leak Follow-up period for all other adverse events was in-hospital until discharge, approximately 30 days.	0.00% 0/24 • Up to 30 days post surgery Follow-up period for all-cause mortality was 30 days. Any air-lead \>5 days to 7 days was documented as Prolonged air leak Follow-up period for all other adverse events was in-hospital until discharge, approximately 30 days.

Additional Information

Sowmy Thuppal, Research Assistant Professor

Southern Illinois University School of Medicine

Phone: 217-545-2320

Email: sthuppal83@siumed.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place