Trial Outcomes & Findings for Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler (NCT NCT03187379)
NCT ID: NCT03187379
Last Updated: 2022-06-21
Results Overview
Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
102 participants
Primary outcome timeframe
24 hours post-surgery
Results posted on
2022-06-21
Participant Flow
Participant milestones
| Measure |
Exparel, Liposomal Bupivacaine
Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing
Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine
|
Control
Subjects in this arm will receive 0.25% bupivacaine alone
Bupivacaine: 60cc Bupivacaine
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
52
|
|
Overall Study
COMPLETED
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Exparel, Liposomal Bupivacaine
n=50 Participants
Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing
Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine
|
Control
n=52 Participants
Subjects in this arm will receive 0.25% bupivacaine alone
Bupivacaine: 60cc Bupivacaine
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.4 Years
n=50 Participants
|
41.2 Years
n=52 Participants
|
44.6 Years
n=102 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=50 Participants
|
42 Participants
n=52 Participants
|
82 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=50 Participants
|
10 Participants
n=52 Participants
|
20 Participants
n=102 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
52 participants
n=52 Participants
|
102 participants
n=102 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-surgeryPatient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.
Outcome measures
| Measure |
Exparel, Liposomal Bupivacaine
n=50 Participants
Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing
Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine
|
Control
n=52 Participants
Subjects in this arm will receive 0.25% bupivacaine alone
Bupivacaine: 60cc Bupivacaine
|
|---|---|---|
|
Post-Operative Pain
|
49.4 units on a Visual Analog Scale (VAS)
Standard Deviation 29
|
56.6 units on a Visual Analog Scale (VAS)
Standard Deviation 26.4
|
SECONDARY outcome
Timeframe: 48 hours post-surgeryPatient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.
Outcome measures
| Measure |
Exparel, Liposomal Bupivacaine
n=50 Participants
Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing
Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine
|
Control
n=52 Participants
Subjects in this arm will receive 0.25% bupivacaine alone
Bupivacaine: 60cc Bupivacaine
|
|---|---|---|
|
Post-Operative Pain
|
42.2 units on a Visual Analog Scale (VAS)
Standard Deviation 30
|
51.5 units on a Visual Analog Scale (VAS)
Standard Deviation 31.4
|
Adverse Events
Exparel, Liposomal Bupivacaine
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Control
Serious events: 15 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exparel, Liposomal Bupivacaine
n=50 participants at risk
Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing
Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine
|
Control
n=52 participants at risk
Subjects in this arm will receive 0.25% bupivacaine alone
Bupivacaine: 60cc Bupivacaine
|
|---|---|---|
|
General disorders
Nausea
|
6.0%
3/50 • Number of events 3 • 1 year
|
5.8%
3/52 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
3/50 • Number of events 3 • 1 year
|
7.7%
4/52 • Number of events 4 • 1 year
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Number of events 1 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
2.0%
1/50 • Number of events 1 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Vascular disorders
Stroke
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/52 • 1 year
|
|
General disorders
Abdominal Pain
|
4.0%
2/50 • Number of events 2 • 1 year
|
9.6%
5/52 • Number of events 5 • 1 year
|
|
Blood and lymphatic system disorders
Bleeding
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
General disorders
Dehydration
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/52 • 1 year
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/50 • 1 year
|
3.8%
2/52 • Number of events 2 • 1 year
|
|
General disorders
Chest Pain
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/52 • 1 year
|
|
General disorders
Left Side Pain
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
General disorders
Right Flank Pain
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
General disorders
Chills
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
General disorders
Fever
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Infections and infestations
Wound Infection
|
2.0%
1/50 • Number of events 1 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post Operative Complications
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/52 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Exparel, Liposomal Bupivacaine
n=50 participants at risk
Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing
Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine
|
Control
n=52 participants at risk
Subjects in this arm will receive 0.25% bupivacaine alone
Bupivacaine: 60cc Bupivacaine
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
General disorders
Abdominal Pain
|
6.0%
3/50 • Number of events 3 • 1 year
|
9.6%
5/52 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
General disorders
Nausea
|
6.0%
3/50 • Number of events 3 • 1 year
|
3.8%
2/52 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • Number of events 2 • 1 year
|
7.7%
4/52 • Number of events 4 • 1 year
|
|
General disorders
Pain- Not otherwise Specified
|
2.0%
1/50 • Number of events 1 • 1 year
|
5.8%
3/52 • Number of events 3 • 1 year
|
|
Infections and infestations
Cellulitis
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/52 • 1 year
|
|
Injury, poisoning and procedural complications
Wound Drainage
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/52 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
2.0%
1/50 • Number of events 1 • 1 year
|
3.8%
2/52 • Number of events 2 • 1 year
|
|
General disorders
Chest Pain
|
8.0%
4/50 • Number of events 4 • 1 year
|
3.8%
2/52 • Number of events 2 • 1 year
|
|
General disorders
Pelvic Pain
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/52 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
2.0%
1/50 • Number of events 1 • 1 year
|
3.8%
2/52 • Number of events 2 • 1 year
|
|
Reproductive system and breast disorders
Vaginal Bleed
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
General disorders
Leg Burn
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Left Ankle Pain
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/52 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Foot Pain
|
4.0%
2/50 • Number of events 2 • 1 year
|
0.00%
0/52 • 1 year
|
|
General disorders
Dehydration
|
0.00%
0/50 • 1 year
|
3.8%
2/52 • Number of events 2 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • 1 year
|
3.8%
2/52 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/50 • 1 year
|
3.8%
2/52 • Number of events 2 • 1 year
|
|
Investigations
Abnormal labs
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Black Stool
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
General disorders
Headache
|
0.00%
0/50 • 1 year
|
3.8%
2/52 • Number of events 2 • 1 year
|
|
General disorders
Left Side Pain
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/52 • 1 year
|
|
General disorders
Swollen Leg
|
2.0%
1/50 • Number of events 1 • 1 year
|
0.00%
0/52 • 1 year
|
|
Eye disorders
Right Eye Complaint
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection- Not otherwise Specified
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
General disorders
Hip Pain
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Infections and infestations
Congestion
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/50 • 1 year
|
1.9%
1/52 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place