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=99 Participants
|
66.5 years
STANDARD_DEVIATION 7.7 • n=107 Participants
|
66 years
STANDARD_DEVIATION 7.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Comorbidities
Hypertension
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Comorbidities
Obesity
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Comorbidities
Diabetes Mellitus
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Comorbidities
COPD
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Comorbidities
Asthma
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Comorbidities
Arthritis
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Comorbidities
GERD
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Comorbidities
Hyperlipidemia
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 72 hours post surgeryMeasured 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 medicationsUsing 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 daysAll 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 daysMedian 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 surgeryAny 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 daysOutcome 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 daysDocumented 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 daysNumber 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 daysPost-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: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place