Trial Outcomes & Findings for TAP Block Using Liposomal Bupivacaine for Post-cesarean Delivery Analgesia- Walking Towards Recovery (NCT NCT04393207)
NCT ID: NCT04393207
Last Updated: 2025-03-21
Results Overview
Morphine milligram equivalents
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
147 participants
Primary outcome timeframe
24 hours
Results posted on
2025-03-21
Participant Flow
Participant milestones
| Measure |
Control Group (Bupivacaine)
Patient will receive intrathecal morphine and TAP block with plain bupivacaine.
Control group (Bupivacaine)- (BPG): Transverse abdominis plane block will be performed with plain bupivacaine
|
Liposomal Bupivacaine
Patient will receive intrathecal morphine + TAP block with Liposomal bupivacaine and bupivacaine 0.25%
Liposomal bupivacaine (LB): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with liposomal bupivacaine + bupivacaine or with bupivacaine alone.
Dexamethasone and methylprednisolone (CG): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
|
Bupivacaine + Dexamethasone and Methylprednisolone
Patient will receive intrathecal morphine + TAP block with only bupivacaine.
Dexamethasone and methylprednisolone (CG): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
60
|
63
|
|
Overall Study
COMPLETED
|
24
|
60
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TAP Block Using Liposomal Bupivacaine for Post-cesarean Delivery Analgesia- Walking Towards Recovery
Baseline characteristics by cohort
| Measure |
Control Group (Bupivacaine)
n=24 Participants
Patient will receive intrathecal morphine and TAP block with plain bupivacaine.
Control group (Bupivacaine)- (BPG): Transverse abdominis plane block will be performed with plain bupivacaine
|
Liposomal Bupivacaine
n=60 Participants
Patient will receive intrathecal morphine + TAP block with Liposomal bupivacaine and bupivacaine 0.25%
Liposomal bupivacaine (LB): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with liposomal bupivacaine + bupivacaine or with bupivacaine alone.
Dexamethasone and methylprednisolone (CG): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
|
Bupivacaine + Dexamethasone and Methylprednisolone
n=63 Participants
Patient will receive intrathecal morphine + TAP block with only bupivacaine.
Dexamethasone and methylprednisolone (CG): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.13 years
STANDARD_DEVIATION 5.86 • n=5 Participants
|
33.66 years
STANDARD_DEVIATION 4.79 • n=7 Participants
|
32.8 years
STANDARD_DEVIATION 5.02 • n=5 Participants
|
33.23 years
STANDARD_DEVIATION 5.08 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
147 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
60 participants
n=7 Participants
|
63 participants
n=5 Participants
|
147 participants
n=4 Participants
|
|
Gestation
|
2.83 pregnancies
STANDARD_DEVIATION 1.4 • n=5 Participants
|
2.9 pregnancies
STANDARD_DEVIATION 1.72 • n=7 Participants
|
2.4 pregnancies
STANDARD_DEVIATION 0.93 • n=5 Participants
|
2.71 pregnancies
STANDARD_DEVIATION 1.42 • n=4 Participants
|
|
Gestation age in weeks
|
53.95 weeks
STANDARD_DEVIATION 75 • n=5 Participants
|
38.32 weeks
STANDARD_DEVIATION 1.62 • n=7 Participants
|
47.36 weeks
STANDARD_DEVIATION 56.07 • n=5 Participants
|
45.02 weeks
STANDARD_DEVIATION 48.49 • n=4 Participants
|
PRIMARY outcome
Timeframe: 24 hoursMorphine milligram equivalents
Outcome measures
| Measure |
Control Group (Bupivacaine)
n=24 Participants
Patient will receive intrathecal morphine and TAP block with plain bupivacaine.
Control group (Bupivacaine)- (BPG): Transverse abdominis plane block will be performed with plain bupivacaine
|
Liposomal Bupivacaine
n=60 Participants
Patient will receive intrathecal morphine + TAP block with Liposomal bupivacaine and bupivacaine 0.25%
Liposomal bupivacaine (LB): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with liposomal bupivacaine + bupivacaine or with bupivacaine alone.
Dexamethasone and methylprednisolone (CG): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
|
Bupivacaine + Dexamethasone and Methylprednisolone
n=63 Participants
Patient will receive intrathecal morphine + TAP block with only bupivacaine.
Dexamethasone and methylprednisolone (CG): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
|
|---|---|---|---|
|
Morphine Milligram Equivalents (MME)
|
5.31 Morphine milligram equivalents
Standard Deviation 8.12
|
5.16 Morphine milligram equivalents
Standard Deviation 10.16
|
5.06 Morphine milligram equivalents
Standard Deviation 9.67
|
PRIMARY outcome
Timeframe: 48 hoursMorphine milligram equivalents
Outcome measures
| Measure |
Control Group (Bupivacaine)
n=24 Participants
Patient will receive intrathecal morphine and TAP block with plain bupivacaine.
Control group (Bupivacaine)- (BPG): Transverse abdominis plane block will be performed with plain bupivacaine
|
Liposomal Bupivacaine
n=60 Participants
Patient will receive intrathecal morphine + TAP block with Liposomal bupivacaine and bupivacaine 0.25%
Liposomal bupivacaine (LB): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with liposomal bupivacaine + bupivacaine or with bupivacaine alone.
Dexamethasone and methylprednisolone (CG): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
|
Bupivacaine + Dexamethasone and Methylprednisolone
n=63 Participants
Patient will receive intrathecal morphine + TAP block with only bupivacaine.
Dexamethasone and methylprednisolone (CG): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
|
|---|---|---|---|
|
Morphine Milligram Equivalents (MME)
|
15.31 Morphine milligram equivalents
Standard Deviation 22.93
|
15.55 Morphine milligram equivalents
Standard Deviation 23.18
|
16.59 Morphine milligram equivalents
Standard Deviation 18.15
|
PRIMARY outcome
Timeframe: 72 hoursMorphine milligram equivalents
Outcome measures
| Measure |
Control Group (Bupivacaine)
n=24 Participants
Patient will receive intrathecal morphine and TAP block with plain bupivacaine.
Control group (Bupivacaine)- (BPG): Transverse abdominis plane block will be performed with plain bupivacaine
|
Liposomal Bupivacaine
n=60 Participants
Patient will receive intrathecal morphine + TAP block with Liposomal bupivacaine and bupivacaine 0.25%
Liposomal bupivacaine (LB): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with liposomal bupivacaine + bupivacaine or with bupivacaine alone.
Dexamethasone and methylprednisolone (CG): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
|
Bupivacaine + Dexamethasone and Methylprednisolone
n=63 Participants
Patient will receive intrathecal morphine + TAP block with only bupivacaine.
Dexamethasone and methylprednisolone (CG): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
|
|---|---|---|---|
|
Morphine Milligram Equivalents (MME)
|
6.56 Morphine milligram equivalents
Standard Deviation 14.72
|
7.81 Morphine milligram equivalents
Standard Deviation 14.51
|
6.56 Morphine milligram equivalents
Standard Deviation 11.16
|
SECONDARY outcome
Timeframe: 24 hours, 48 hours, 72 hoursUse of a validated questionnaire to measure recovery after cesarean delivery ObsQoR-11. Total score ranging from 0 to 100, with a higher score indicating a better quality of recovery after a caesarean delivery.
Outcome measures
| Measure |
Control Group (Bupivacaine)
n=24 Participants
Patient will receive intrathecal morphine and TAP block with plain bupivacaine.
Control group (Bupivacaine)- (BPG): Transverse abdominis plane block will be performed with plain bupivacaine
|
Liposomal Bupivacaine
n=60 Participants
Patient will receive intrathecal morphine + TAP block with Liposomal bupivacaine and bupivacaine 0.25%
Liposomal bupivacaine (LB): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with liposomal bupivacaine + bupivacaine or with bupivacaine alone.
Dexamethasone and methylprednisolone (CG): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
|
Bupivacaine + Dexamethasone and Methylprednisolone
n=63 Participants
Patient will receive intrathecal morphine + TAP block with only bupivacaine.
Dexamethasone and methylprednisolone (CG): Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
|
|---|---|---|---|
|
Self Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)
24 hours
|
83 score on a scale
Standard Deviation 15.3
|
84 score on a scale
Standard Deviation 16.1
|
85.2 score on a scale
Standard Deviation 15.6
|
|
Self Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)
48 hours
|
80.8 score on a scale
Standard Deviation 16.7
|
87.1 score on a scale
Standard Deviation 16.6
|
86.6 score on a scale
Standard Deviation 15.5
|
|
Self Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)
72 hours
|
86 score on a scale
Standard Deviation 41.9
|
90.4 score on a scale
Standard Deviation 41.5
|
86 score on a scale
Standard Deviation 36.7
|
Adverse Events
Control Group (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
Bupivacaine + Dexamethasone and Methylprednisolone
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