Trial Outcomes & Findings for Comparison of Exparel to Bupivacaine With Dexamethasone in TAP Block (NCT NCT02179892)
NCT ID: NCT02179892
Last Updated: 2017-08-11
Results Overview
The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
9 participants
Primary outcome timeframe
Post Surgery (Up to 72 Hours)
Results posted on
2017-08-11
Participant Flow
Participants were recruited from the Emory University Hospital and the Emory University Hospital Midtown between July 2014 through June 2015.
Participant milestones
| Measure |
Group 1-Exparel
Bupivacaine Extended-Release Liposome Injection (Exparel) were administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block.
|
Group 2-Bupivacaine and Dexamethasone IV
Bupivacaine and Dexamethasone Injection were administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
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 |
Group 1-Exparel
n=5 Participants
Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block
|
Group 2-Bupivacaine and Dexamethasone IV
n=4 Participants
Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=9 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
9 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Post Surgery (Up to 72 Hours)The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group.
Outcome measures
| Measure |
Group 1-Exparel
n=5 Participants
Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block
|
Group 2-Bupivacaine and Dexamethasone IV
n=4 Participants
Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block.
|
|---|---|---|
|
Mean Opioid Consumption
|
507 milligrams
Standard Deviation 602
|
392 milligrams
Standard Deviation 133
|
SECONDARY outcome
Timeframe: Post-Surgery 24 Hours, 48 Hours, 72 HoursThe VAS method of pain assessment (scale of 1- 10) will be used to measure the participant's pain level at rest each day during the 72 hours post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.
Outcome measures
| Measure |
Group 1-Exparel
n=5 Participants
Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block
|
Group 2-Bupivacaine and Dexamethasone IV
n=4 Participants
Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block.
|
|---|---|---|
|
Mean Visual Analogue Scale (VAS) Pain Score at Rest
24 Hours Post Surgery
|
4.2 units on a scale
Standard Deviation 1.9
|
3.5 units on a scale
Standard Deviation 1.3
|
|
Mean Visual Analogue Scale (VAS) Pain Score at Rest
48 Hours Post Surgery
|
1.8 units on a scale
Standard Deviation 1.6
|
3.3 units on a scale
Standard Deviation 2.6
|
|
Mean Visual Analogue Scale (VAS) Pain Score at Rest
72 Hours Post Surgery
|
1.8 units on a scale
Standard Deviation 2.0
|
3.5 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Post-Surgery 24 Hours, 48 Hours, 72 HoursThe VAS method of pain assessment (scale of 1-10) will be used to measure the patient's level of pain with movement each day during the 72 hour post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.
Outcome measures
| Measure |
Group 1-Exparel
n=5 Participants
Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block
|
Group 2-Bupivacaine and Dexamethasone IV
n=4 Participants
Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block.
|
|---|---|---|
|
Mean Visual Analogue Scale (VAS) Pain Score With Movement
24 Hours Post Surgery
|
6.8 units on a scale
Standard Deviation 3.4
|
5.8 units on a scale
Standard Deviation 1.7
|
|
Mean Visual Analogue Scale (VAS) Pain Score With Movement
48 Hours Post Surgery
|
6.6 units on a scale
Standard Deviation 4.1
|
6.3 units on a scale
Standard Deviation 3.3
|
|
Mean Visual Analogue Scale (VAS) Pain Score With Movement
72 Hours Post Surgery
|
3.6 units on a scale
Standard Deviation 2.9
|
4.8 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Post-surgery (Up to 72 Hours)The time of first opioid use after surgery will be recorded for up to 72 hours.
Outcome measures
| Measure |
Group 1-Exparel
n=5 Participants
Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block
|
Group 2-Bupivacaine and Dexamethasone IV
n=4 Participants
Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block.
|
|---|---|---|
|
Mean Time of First Opioid Use
|
58 hours
Standard Deviation 29
|
46 hours
Standard Deviation 31
|
Adverse Events
Group 1-Exparel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2-Bupivacaine and Dexamethasone IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place