Trial Outcomes & Findings for Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy (NCT NCT03250507)
NCT ID: NCT03250507
Last Updated: 2022-12-21
Results Overview
Total opioid consumption
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
0 - 72 hours post-operatively
Results posted on
2022-12-21
Participant Flow
Participant milestones
| Measure |
Bupivacaine
Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
Bupivacaine: 0.25% bupivacaine for TAP block
|
Liposomal Bupivacaine
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
Liposomal bupivacaine: Exparel for TAP block
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
|
Liposomal Bupivacaine and Bupivacaine
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
Bupivacaine: 0.25% bupivacaine for TAP block
Liposomal bupivacaine: Exparel for TAP block
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
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 |
Bupivacaine
n=30 Participants
Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
Bupivacaine: 0.25% bupivacaine for TAP block
|
Liposomal Bupivacaine
n=30 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
Liposomal bupivacaine: Exparel for TAP block
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
|
Liposomal Bupivacaine and Bupivacaine
n=30 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
Bupivacaine: 0.25% bupivacaine for TAP block
Liposomal bupivacaine: Exparel for TAP block
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=90 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
90 Participants
n=90 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=90 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
30 Participants
n=30 Participants
|
90 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=90 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
30 participants
n=30 Participants
|
90 participants
n=90 Participants
|
PRIMARY outcome
Timeframe: 0 - 72 hours post-operativelyTotal opioid consumption
Outcome measures
| Measure |
Liposomal Bupivacaine and Bupivacaine
n=19 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
Bupivacaine: 0.25% bupivacaine for TAP block
Liposomal bupivacaine: Exparel for TAP block
|
Liposomal Bupivacaine
n=20 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
Liposomal bupivacaine: Exparel for TAP block
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
|
Bupivacaine
n=18 Participants
Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
Bupivacaine: 0.25% bupivacaine for TAP block
|
|---|---|---|---|
|
Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)
|
202 mg morphine equivalents
Interval 116.0 to 325.0
|
203 mg morphine equivalents
Interval 153.0 to 283.0
|
208 mg morphine equivalents
Interval 155.0 to 270.0
|
PRIMARY outcome
Timeframe: 0 - 72 hours post-operativelytime to first opioid given
Outcome measures
| Measure |
Liposomal Bupivacaine and Bupivacaine
n=25 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
Bupivacaine: 0.25% bupivacaine for TAP block
Liposomal bupivacaine: Exparel for TAP block
|
Liposomal Bupivacaine
n=27 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
Liposomal bupivacaine: Exparel for TAP block
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
|
Bupivacaine
n=25 Participants
Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
Bupivacaine: 0.25% bupivacaine for TAP block
|
|---|---|---|---|
|
Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given
|
51 minutes
Interval 24.0 to 84.0
|
63 minutes
Interval 44.0 to 102.0
|
51 minutes
Interval 28.0 to 66.0
|
SECONDARY outcome
Timeframe: 0 - 72 hours post-operativelyPatient satisfaction post-operatively. The number of patients who were very satisfied is reported.
Outcome measures
| Measure |
Liposomal Bupivacaine and Bupivacaine
n=25 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
Bupivacaine: 0.25% bupivacaine for TAP block
Liposomal bupivacaine: Exparel for TAP block
|
Liposomal Bupivacaine
n=27 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
Liposomal bupivacaine: Exparel for TAP block
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
|
Bupivacaine
n=25 Participants
Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
Bupivacaine: 0.25% bupivacaine for TAP block
|
|---|---|---|---|
|
Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied
|
9 participants
|
13 participants
|
9 participants
|
SECONDARY outcome
Timeframe: until the patient is discharged from the hospitalLength of stay in the hospital, maximum time until discharge from the hospital
Outcome measures
| Measure |
Liposomal Bupivacaine and Bupivacaine
n=25 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
Bupivacaine: 0.25% bupivacaine for TAP block
Liposomal bupivacaine: Exparel for TAP block
|
Liposomal Bupivacaine
n=27 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
Liposomal bupivacaine: Exparel for TAP block
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
|
Bupivacaine
n=25 Participants
Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
Bupivacaine: 0.25% bupivacaine for TAP block
|
|---|---|---|---|
|
Length of Stay in the Hospital
|
80 hours
Interval 76.0 to 107.0
|
82 hours
Interval 72.0 to 102.0
|
79 hours
Interval 61.0 to 122.0
|
SECONDARY outcome
Timeframe: 0 - 72 hours post-operativelyPresence of local anesthetic toxicity
Outcome measures
| Measure |
Liposomal Bupivacaine and Bupivacaine
n=25 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
Bupivacaine: 0.25% bupivacaine for TAP block
Liposomal bupivacaine: Exparel for TAP block
|
Liposomal Bupivacaine
n=27 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
Liposomal bupivacaine: Exparel for TAP block
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
|
Bupivacaine
n=25 Participants
Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
Bupivacaine: 0.25% bupivacaine for TAP block
|
|---|---|---|---|
|
Number of Patients With Local Anesthetic Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 - 72 hours post-operativelyPresence of hemodynamic instability
Outcome measures
| Measure |
Liposomal Bupivacaine and Bupivacaine
n=25 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
Bupivacaine: 0.25% bupivacaine for TAP block
Liposomal bupivacaine: Exparel for TAP block
|
Liposomal Bupivacaine
n=27 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
Liposomal bupivacaine: Exparel for TAP block
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
|
Bupivacaine
n=25 Participants
Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
Bupivacaine: 0.25% bupivacaine for TAP block
|
|---|---|---|---|
|
Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure
|
5 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-24 postoperative pain scoresMaximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.
Outcome measures
| Measure |
Liposomal Bupivacaine and Bupivacaine
n=25 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine.
Bupivacaine: 0.25% bupivacaine for TAP block
Liposomal bupivacaine: Exparel for TAP block
|
Liposomal Bupivacaine
n=27 Participants
Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine.
Liposomal bupivacaine: Exparel for TAP block
Saline: Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
|
Bupivacaine
n=25 Participants
Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
Bupivacaine: 0.25% bupivacaine for TAP block
|
|---|---|---|---|
|
Pain Scores Using Visual Analogue Scale ( 0-10)
|
7 units on a scale
Interval 5.0 to 8.0
|
7 units on a scale
Interval 6.0 to 7.0
|
8 units on a scale
Interval 7.0 to 9.0
|
Adverse Events
Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Liposomal Bupivacaine and Bupivacaine
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