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TAP Block Using Liposomal Bupivacaine for Post-cesarean Delivery Analgesia- Walking Towards Recovery

Transverse Abdominis Plane Block Using Liposomal Bupivacaine for Post-operative Cesarean Delivery Analgesia- Walking Towards Recovery

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04393207
Enrollment
147
Registered
2020-05-19
Start date
2022-02-01
Completion date
2023-11-28
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use, Pain, Acute

Brief summary

The TAP block offers analgesia by blocking the sensory nerves of the anterior abdominal wall. The procedure is performed under ultrasound guidance, after identification of the external oblique, internal oblique and transverse abdominis muscle. Medication is injected in the neurofascial plane between the internal oblique and the tranversus abdominis muscle. Previous studies have demonstrated limited (\<24 hour) effect of the block when compared to the use of intrathecal morphine (considered to be the gold standard for postoperative analgesia). In a study by McMarrow et al., post-caesarian pain control combinations including TAP blocks with local anesthetic (Bupivacaine) or saline after a spinal anesthetic with or without intrathecal morphine were compared. At 6 hours the Morphine consumption was slightly reduced in the patients that received both intrathecal morphine and TAP blocks with LA when compared to patients that received spinal saline and TAP with saline. At 24 hours the TAP block conferred no benefit in terms of opioid consumption. Similarly, the study by Lee et al. demonstrated better pain scores for the first 2 hours in patients receiving both intrathecal morphine and a TAP block with ropivacaine. At 24 hours there was no difference in the pain scores for patients that received both intrathecal morphine and TAP blocks. On the contrary, a more recent study utilizing liposomal bupivacaine has been utilized for TAP blocks for post cesarean delivery analgesia, demonstrating opioid reductions for up to 72 hours. Liposomal bupivacaine is a novel, multivesicular formulation designed for rapid absorption, prolonged release of bupivacaine, and analgesia following a single intra-operative administration into the surgical wound or for TAP blocks. Current anesthesia practices encourage the use of multimodal analgesia that aim at enhanced recovery after surgery (ERAS). The ERAS model aims to decrease immobility, pain and post-operative ileus. Pain and immobility may be closely related, and the latter has rarely been monitored in the post-operative setting. It is planned to use a research validated fit-bit like device (Actigraph GT3-X) to monitor patient steps (mobility).

Detailed description

This is a double blinded, randomized controlled trial. The study will be composed of 3 groups Group 1- Transverse abdominus plain block with liposomal bupivacaine + bupivacaine (LB) Group 2 - Transverse abdominus plain block with bupivacaine (BP) Group 3 - Control group (standard of care with no TAP) 1. Patients will be asked to participate after meeting their anesthesia team and giving verbal consent to receive spinal anesthesia for their cesarean delivery. 2. A computer-generated, single block randomization scheme will be used to allocate patients to one of the three groups (Control group (bupivacaine) Vs TAP LB group or corticosteroid group). 3. In the OR, a spinal using 10-12 mg bupivacaine 0.75%, 10 mcg Fentanyl and 0.1 mg preservative free intrathecal morphine will be performed. Patients will receive IV acetaminophen 1 gram, before skin incision and ketorolac 30 mg after closure of fascia. All patients will receive the same postoperative analgesia orders, which include Tylenol, Ibuprofen and opioids for breakthrough pain. (standard of care) After wound closure a TAP block will be performed according to randomization process as described above. 4. The LB TAP block group will receive bilateral ultrasound guided block utilizing 10 ml of liposomal bupivacaine\* and 20 ml of 0.25% bupivacaine. The BP TAP group will receive bilateral ultrasound guided block utilizing 20 ml of 0.25% bupivacaine.(Research procedure) 5. The control group will be approached in the exact same way the TAP block group, that is, the ultrasound would be used to identify the muscle layer, but a covered needle will be used to simulate a TAP block. The randomization and procedure will be handled by a co-investigator not involved in the evaluation or data collection at the stablished time points. Patients will be recruited from 7am-5pm and for elective CD 6. The control group will receive Bupivacaine 25 ml of sensorcaine 0.25% + 5 ml saline flush 7. The corticosteroid group will receive sensorcaince 0.25% -20 ml + 10 mg dexamethasone (0.5 ml) + 40 mg methylprednisolone (1 ml) + 8.5 ml normal saline 8. Patients will be asked to complete the ObsQoR-11 at 24 hours, 48 hours and 72 hours. All patients in this study will be receiving the standard of care. The current standard of care is spinal anesthesia inclusive of intrathecal morphine.

Interventions

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.

DRUGDexamethasone 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.

DRUGControl group (Bupivacaine)- (BPG)

Transverse abdominis plane block will be performed with plain bupivacaine

Sponsors

Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patients between the ages of 18 and 45 presenting for cesarean delivery 2. ASA-1, ASA-2, ASA-3 3. No allergy to morphine 4. No allergy to bupivacaine 5. Patients with BMI \> 45 will be excluded 6. No history of anxiety 7. No recent or chronic opioid use

Exclusion criteria

1. Need for Magnesium sulfate therapy 2. Neonatal admission to neonatal intensive care unit 3. Need for additional surgery other than cesarean delivery +/- bilateral tubal ligation (e.g. hysterectomy, cystotomy)

Design outcomes

Primary

MeasureTime frameDescription
Morphine Milligram Equivalents (MME)24 hoursMorphine milligram equivalents

Secondary

MeasureTime frameDescription
Self Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
24
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.
60
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.
63
Total147

Baseline characteristics

CharacteristicControl Group (Bupivacaine)Liposomal BupivacaineBupivacaine + Dexamethasone and MethylprednisoloneTotal
Age, Continuous33.13 years
STANDARD_DEVIATION 5.86
33.66 years
STANDARD_DEVIATION 4.79
32.8 years
STANDARD_DEVIATION 5.02
33.23 years
STANDARD_DEVIATION 5.08
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants11 Participants10 Participants28 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants49 Participants53 Participants119 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Gestation2.83 pregnancies
STANDARD_DEVIATION 1.4
2.9 pregnancies
STANDARD_DEVIATION 1.72
2.4 pregnancies
STANDARD_DEVIATION 0.93
2.71 pregnancies
STANDARD_DEVIATION 1.42
Gestation age in weeks53.95 weeks
STANDARD_DEVIATION 75
38.32 weeks
STANDARD_DEVIATION 1.62
47.36 weeks
STANDARD_DEVIATION 56.07
45.02 weeks
STANDARD_DEVIATION 48.49
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants9 Participants12 Participants
Race (NIH/OMB)
Black or African American
3 Participants9 Participants3 Participants15 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants3 Participants5 Participants13 Participants
Race (NIH/OMB)
White
15 Participants46 Participants46 Participants107 Participants
Region of Enrollment
United States
24 participants60 participants63 participants147 participants
Sex: Female, Male
Female
24 Participants60 Participants63 Participants147 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 600 / 63
other
Total, other adverse events
0 / 240 / 600 / 63
serious
Total, serious adverse events
0 / 240 / 600 / 63

Outcome results

Primary

Morphine Milligram Equivalents (MME)

Morphine milligram equivalents

Time frame: 24 hours

ArmMeasureValue (MEAN)Dispersion
Control Group (Bupivacaine)Morphine Milligram Equivalents (MME)5.31 Morphine milligram equivalentsStandard Deviation 8.12
Liposomal BupivacaineMorphine Milligram Equivalents (MME)5.16 Morphine milligram equivalentsStandard Deviation 10.16
Bupivacaine + Dexamethasone and MethylprednisoloneMorphine Milligram Equivalents (MME)5.06 Morphine milligram equivalentsStandard Deviation 9.67
Primary

Morphine Milligram Equivalents (MME)

Morphine milligram equivalents

Time frame: 48 hours

ArmMeasureValue (MEAN)Dispersion
Control Group (Bupivacaine)Morphine Milligram Equivalents (MME)15.31 Morphine milligram equivalentsStandard Deviation 22.93
Liposomal BupivacaineMorphine Milligram Equivalents (MME)15.55 Morphine milligram equivalentsStandard Deviation 23.18
Bupivacaine + Dexamethasone and MethylprednisoloneMorphine Milligram Equivalents (MME)16.59 Morphine milligram equivalentsStandard Deviation 18.15
Primary

Morphine Milligram Equivalents (MME)

Morphine milligram equivalents

Time frame: 72 hours

ArmMeasureValue (MEAN)Dispersion
Control Group (Bupivacaine)Morphine Milligram Equivalents (MME)6.56 Morphine milligram equivalentsStandard Deviation 14.72
Liposomal BupivacaineMorphine Milligram Equivalents (MME)7.81 Morphine milligram equivalentsStandard Deviation 14.51
Bupivacaine + Dexamethasone and MethylprednisoloneMorphine Milligram Equivalents (MME)6.56 Morphine milligram equivalentsStandard Deviation 11.16
Secondary

Self Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)

Use 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.

Time frame: 24 hours, 48 hours, 72 hours

ArmMeasureGroupValue (MEAN)Dispersion
Control Group (Bupivacaine)Self Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)48 hours80.8 score on a scaleStandard Deviation 16.7
Control Group (Bupivacaine)Self Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)24 hours83 score on a scaleStandard Deviation 15.3
Control Group (Bupivacaine)Self Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)72 hours86 score on a scaleStandard Deviation 41.9
Liposomal BupivacaineSelf Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)48 hours87.1 score on a scaleStandard Deviation 16.6
Liposomal BupivacaineSelf Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)24 hours84 score on a scaleStandard Deviation 16.1
Liposomal BupivacaineSelf Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)72 hours90.4 score on a scaleStandard Deviation 41.5
Bupivacaine + Dexamethasone and MethylprednisoloneSelf Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)24 hours85.2 score on a scaleStandard Deviation 15.6
Bupivacaine + Dexamethasone and MethylprednisoloneSelf Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)72 hours86 score on a scaleStandard Deviation 36.7
Bupivacaine + Dexamethasone and MethylprednisoloneSelf Assessed Recovery Survey Obstetric Quality-of-Recovery Score (ObsQoR-11)48 hours86.6 score on a scaleStandard Deviation 15.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026