Trial Outcomes & Findings for Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®) (NCT NCT03723447)
NCT ID: NCT03723447
Last Updated: 2021-02-17
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
102 participants
Primary outcome timeframe
48-hours
Results posted on
2021-02-17
Participant Flow
One patient was noted to have chronic opioid use discovered after randomization. They were subsequently excluded from analysis
Participant milestones
| Measure |
Bupivacaine/Epinephrine/Dexamethasone TAP Block
For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.
Bupivacaine/epinephrine/dexamethasone: Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.
|
Liposomal Bupivacaine TAP Block
For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.
Liposomal bupivacaine: Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
COMPLETED
|
50
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intraoperative TAP Block With Bupivacaine/Dexamethasone Against Liposomal Bupivacaine (Exparel®)
Baseline characteristics by cohort
| Measure |
Bupivacaine/Epinephrine/Dexamethasone TAP Block
n=50 Participants
For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.
Bupivacaine/epinephrine/dexamethasone: Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.
|
Liposomal Bupivacaine TAP Block
n=51 Participants
For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.
Liposomal bupivacaine: Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
n=93 Participants
|
42 years
n=4 Participants
|
42 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=93 Participants
|
51 participants
n=4 Participants
|
101 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 48-hoursOutcome measures
| Measure |
Bupivacaine/Epinephrine/Dexamethasone TAP Block
n=50 Participants
For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.
Bupivacaine/epinephrine/dexamethasone: Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.
|
Liposomal Bupivacaine TAP Block
n=51 Participants
For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.
Liposomal bupivacaine: Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.
|
|---|---|---|
|
Cumulative 48-hour Post Surgical Opiate Use (Oral Morphine Equivalent)
|
47 Oral morphine equivalents
Interval 18.0 to 112.0
|
69 Oral morphine equivalents
Interval 20.0 to 110.0
|
SECONDARY outcome
Timeframe: 72-hours post-surgeryVisual pain scale recordings will be totaled and averaged during the first 72-hours post-surgery. Visual analog scale is determined by nursing staff when assessing pain scores. Scores range from 0-10 with 10 being the most pain. These values are typically interpreted by nursing staff as mild, moderate, or severe pain and pain medication is given accordingly.
Outcome measures
| Measure |
Bupivacaine/Epinephrine/Dexamethasone TAP Block
n=50 Participants
For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.
Bupivacaine/epinephrine/dexamethasone: Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.
|
Liposomal Bupivacaine TAP Block
n=51 Participants
For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.
Liposomal bupivacaine: Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.
|
|---|---|---|
|
Post-op Pain Score (Visual Analog Scale)
|
4 score on a scale
Interval 2.0 to 5.0
|
4 score on a scale
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: 72 hours post-surgeryTime till first bowel movement
Outcome measures
| Measure |
Bupivacaine/Epinephrine/Dexamethasone TAP Block
n=50 Participants
For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.
Bupivacaine/epinephrine/dexamethasone: Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.
|
Liposomal Bupivacaine TAP Block
n=51 Participants
For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.
Liposomal bupivacaine: Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.
|
|---|---|---|
|
Bowel Motility
|
1 days
Interval 1.0 to 2.0
|
1 days
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: 30 days post-surgeryTime from operation until hospital discharge
Outcome measures
| Measure |
Bupivacaine/Epinephrine/Dexamethasone TAP Block
n=50 Participants
For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.
Bupivacaine/epinephrine/dexamethasone: Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.
|
Liposomal Bupivacaine TAP Block
n=51 Participants
For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.
Liposomal bupivacaine: Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.
|
|---|---|---|
|
Postoperative Length of Stay
|
3 days
Interval 2.0 to 4.0
|
3 days
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: 30 days post-surgeryMedical or surgical complications measured by Clavien-Dindo classification Clavien-Dindo grade I: any deviation from normal postoperative course * no pharmacological or surgical treatment, endoscopic, or radiological interventions were required. Acceptable therapeutic regiments are drugs such as anti-emetics, antipyretics, analgesics, diuretics, and electrolytes. Wound infections or small abscess requiring incision at bedside is within this category Clavien-Dindo grade II: Normal course altered * Pharacological management other than in grade 1. Blood transfusions and total parenteral nutrition are also included. Clavien-Dindo grade III: complications that require intervention of various degrees * management of these complications require an intervention under local anesthesia or general or epidural anesthesia Clavien-Dindo grade IV: complications threatening the life of a patient * manifesting in organ dysfunction, including dialysis
Outcome measures
| Measure |
Bupivacaine/Epinephrine/Dexamethasone TAP Block
n=50 Participants
For the bupivacaine/epinephrine/dexamethasone treatment arm, a standard weight-based dose of bupivacaine and epinephrine combined with 8mg dexamethasone will be administered.
Bupivacaine/epinephrine/dexamethasone: Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.
|
Liposomal Bupivacaine TAP Block
n=51 Participants
For the liposomal bupivacaine treatment arm, 266mg liposomal bupivacaine (Exparel) will be administered.
Liposomal bupivacaine: Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.
|
|---|---|---|
|
Postoperative Complications
None
|
29 Participants
|
32 Participants
|
|
Postoperative Complications
Clavien-Dindo grade I
|
7 Participants
|
2 Participants
|
|
Postoperative Complications
Clavien-Dindo grade II
|
8 Participants
|
7 Participants
|
|
Postoperative Complications
Clavien-Dindo grade III
|
6 Participants
|
10 Participants
|
Adverse Events
Bupivacaine/Epinephrine/Dexamethasone TAP Block
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Liposomal Bupivacaine TAP Block
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