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Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients (BEMP)

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ClinicalTrials.gov Identifier: NCT03682224
Recruitment Status : Completed
First Posted : September 24, 2018
Results First Posted : January 12, 2023
Last Update Posted : January 12, 2023
Sponsor:
Information provided by (Responsible Party):
Southern Illinois University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Non Small Cell Lung Cancer
Lung Cancer Stage 1
Interventions Drug: Liposomal Bupivacaine
Drug: Bupivacaine-Epinephrine
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exparel Marcaine
Hide Arm/Group Description Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Period Title: Overall Study
Started 29 28
Completed 26 24
Not Completed 3 4
Arm/Group Title Exparel Marcaine Total
Hide Arm/Group Description Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site Total of all reporting groups
Overall Number of Baseline Participants 26 24 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 24 participants 50 participants
65.6  (7.6) 66.5  (7.7) 66  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Female
13
  50.0%
13
  54.2%
26
  52.0%
Male
13
  50.0%
11
  45.8%
24
  48.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
26
 100.0%
24
 100.0%
50
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   7.7%
1
   4.2%
3
   6.0%
White
24
  92.3%
23
  95.8%
47
  94.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Comorbidities  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 26 participants 24 participants 50 participants
Hypertension
19
  73.1%
19
  79.2%
38
  76.0%
Obesity
7
  26.9%
5
  20.8%
12
  24.0%
Diabetes Mellitus
4
  15.4%
7
  29.2%
11
  22.0%
COPD
5
  19.2%
9
  37.5%
14
  28.0%
Asthma
4
  15.4%
1
   4.2%
5
  10.0%
Arthritis
4
  15.4%
1
   4.2%
5
  10.0%
GERD
8
  30.8%
8
  33.3%
16
  32.0%
Hyperlipidemia
13
  50.0%
14
  58.3%
27
  54.0%
1.Primary Outcome
Title Total Morphine Equivalents Consumed
Hide Description Measured as overall intake of any drugs in the opioid class (Morphine Equivalent Dosing)
Time Frame up to 72 hours post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exparel Marcaine
Hide Arm/Group Description:
Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site
Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Overall Number of Participants Analyzed 26 24
Median (Inter-Quartile Range)
Unit of Measure: MEq
48
(23 to 71)
42.7
(28.4 to 55.5)
2.Secondary Outcome
Title VAS Pain Score
Hide Description 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.
Time Frame In-hospital until discharge, approximately 3 days, will be collected each time before dispensing pain medications
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exparel Marcaine
Hide Arm/Group Description:
Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site
Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Overall Number of Participants Analyzed 26 24
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
4.8
(4.3 to 6.2)
5.2
(4.2 to 6.6)
3.Secondary Outcome
Title Treatment Cost
Hide Description All direct cost from the date of surgery until discharge
Time Frame In-hospital Costs until discharge, approximately 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exparel Marcaine
Hide Arm/Group Description:
Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site
Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Overall Number of Participants Analyzed 26 24
Median (Inter-Quartile Range)
Unit of Measure: United States Dollars
22,775
(19,930 to 30,659)
20,252
(18,225 to 25,521)
4.Secondary Outcome
Title Pharmacy Cost
Hide Description Median In-hospital pharmacy cost
Time Frame In-hospital until discharge, approximately 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exparel Marcaine
Hide Arm/Group Description:
Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site
Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Overall Number of Participants Analyzed 26 24
Median (Inter-Quartile Range)
Unit of Measure: United States Dollars
1052
(970 to 1295)
596
(497 to 738)
5.Secondary Outcome
Title Mortality
Hide Description Any death occurring during primary hospital stay or prior to 30 days post surgery
Time Frame Up to 30 days post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exparel Marcaine
Hide Arm/Group Description:
Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site
Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Overall Number of Participants Analyzed 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
6.Other Pre-specified Outcome
Title Hospital Stay
Hide Description [Not Specified]
Time Frame Length of hospital stay - from admission to discharge, approximately 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exparel Marcaine
Hide Arm/Group Description:
Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site
Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Overall Number of Participants Analyzed 26 24
Median (Inter-Quartile Range)
Unit of Measure: Days
3.28
(2.16 to 4.27)
2.45
(2.08 to 3.45)
7.Other Pre-specified Outcome
Title Pneumothorax
Hide Description Documented pnuemothorax
Time Frame In-hospital until discharge, approximately 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exparel Marcaine
Hide Arm/Group Description:
Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site
Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Overall Number of Participants Analyzed 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
5
  19.2%
6
  25.0%
8.Other Pre-specified Outcome
Title Prolonged Air Leak
Hide Description Number of patients who had air leak more than 5 days post-surgery
Time Frame > 5 days to 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exparel Marcaine
Hide Arm/Group Description:
Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site
Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Overall Number of Participants Analyzed 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
8
  30.8%
5
  20.8%
9.Other Pre-specified Outcome
Title Atrial Fibrillation/Other Arrhythmia
Hide Description Post-op arrhythmia
Time Frame In-hospital until discharge, approximately 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Exparel Marcaine
Hide Arm/Group Description:
Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site
Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
Overall Number of Participants Analyzed 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
2
   7.7%
3
  12.5%
Time Frame Up to 30 days post surgery
Adverse Event Reporting Description 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.
 
Arm/Group Title Exparel Marcaine
Hide Arm/Group Description Liposomal Bupivacaine: Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site Bupivacaine-Epinephrine: Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
All-Cause Mortality
Exparel Marcaine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/24 (0.00%) 
Hide Serious Adverse Events
Exparel Marcaine
Affected / at Risk (%) Affected / at Risk (%)
Total   12/26 (46.15%)   9/24 (37.50%) 
Cardiac disorders     
Atrial Fibrillation/Other Arrhythmia †  2/26 (7.69%)  3/24 (12.50%) 
Infections and infestations     
Infection †  2/26 (7.69%)  0/24 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Prolonged air leak †  8/26 (30.77%)  5/24 (20.83%) 
Pneumothorax †  5/26 (19.23%)  6/24 (25.00%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Exparel Marcaine
Affected / at Risk (%) Affected / at Risk (%)
Total   2/26 (7.69%)   1/24 (4.17%) 
Gastrointestinal disorders     
Ileus †  1/26 (3.85%)  0/24 (0.00%) 
Renal and urinary disorders     
Acute Renal Failure †  1/26 (3.85%)  1/24 (4.17%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sowmy Thuppal, Research Assistant Professor
Organization: Southern Illinois University School of Medicine
Phone: 217-545-2320
EMail: sthuppal83@siumed.edu
Layout table for additonal information
Responsible Party: Southern Illinois University
ClinicalTrials.gov Identifier: NCT03682224    
Other Study ID Numbers: CRABTREE-18-185
First Submitted: July 10, 2018
First Posted: September 24, 2018
Results First Submitted: October 25, 2022
Results First Posted: January 12, 2023
Last Update Posted: January 12, 2023