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Slow/low recruitment, unable to recruit
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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).
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)
Patients will be asked to participate after meeting their anesthesia team and giving verbal consent to receive spinal anesthesia for their cesarean delivery.
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).
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.
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)
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
The control group will receive Bupivacaine 25 ml of sensorcaine 0.25% + 5 ml saline flush
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (Bupivacaine) | Active Comparator | Patient will receive intrathecal morphine and TAP block with plain bupivacaine. |
|
| Liposomal Bupivacaine | Experimental | Patient will receive intrathecal morphine + TAP block with Liposomal bupivacaine and bupivacaine 0.25% |
|
| Bupivacaine + dexamethasone and methylprednisolone | Active Comparator | Patient will receive intrathecal morphine + TAP block with only bupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine (LB) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Milligram Equivalents (MME) | Morphine milligram equivalents | 24 hours |
| Morphine Milligram Equivalents (MME) | Morphine milligram equivalents | 48 hours |
| Morphine Milligram Equivalents (MME) | Morphine milligram equivalents | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours, 48 hours, 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Gonzalez, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24012493 | Background | Lee AJ, Palte HD, Chehade JM, Arheart KL, Ranasinghe JS, Penning DH. Ultrasound-guided bilateral transversus abdominis plane blocks in conjunction with intrathecal morphine for postcesarean analgesia. J Clin Anesth. 2013 Sep;25(6):475-82. doi: 10.1016/j.jclinane.2013.05.004. Epub 2013 Sep 3. | |
| 21498494 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Liposomal Bupivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Morphine Milligram Equivalents (MME) | Morphine milligram equivalents | Posted | Mean | Standard Deviation | Morphine milligram equivalents | 24 hours |
|
72 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio Gonzalez | Yale | 203.785.2802 | antonio.gonzalez-fiol@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 29, 2024 | Feb 26, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D008775 | Methylprednisolone |
| D035061 | Control Groups |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| Dexamethasone and methylprednisolone (CG) | Drug | 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. |
|
|
| Control group (Bupivacaine)- (BPG) | Drug | Transverse abdominis plane block will be performed with plain bupivacaine |
|
|
| McMorrow RC, Ni Mhuircheartaigh RJ, Ahmed KA, Aslani A, Ng SC, Conrick-Martin I, Dowling JJ, Gaffney A, Loughrey JP, McCaul CL. Comparison of transversus abdominis plane block vs spinal morphine for pain relief after Caesarean section. Br J Anaesth. 2011 May;106(5):706-12. doi: 10.1093/bja/aer061. |
| 30573987 | Background | Baker BW, Villadiego LG, Lake YN, Amin Y, Timmins AE, Swaim LS, Ashton DW. Transversus abdominis plane block with liposomal bupivacaine for pain control after cesarean delivery: a retrospective chart review. J Pain Res. 2018 Dec 10;11:3109-3116. doi: 10.2147/JPR.S184279. eCollection 2018. |
| 23433933 | Background | Jacques V, Vial F, Lerintiu M, Thilly N, Mc Nelis U, Raft J, Bouaziz H. [Enhanced recovery following uncomplicated elective caesarean section in France: a survey of national practice]. Ann Fr Anesth Reanim. 2013 Mar;32(3):142-8. doi: 10.1016/j.annfar.2013.01.016. Epub 2013 Feb 19. French. |
| 26907794 | Background | Alharbi M, Bauman A, Neubeck L, Gallagher R. Validation of Fitbit-Flex as a measure of free-living physical activity in a community-based phase III cardiac rehabilitation population. Eur J Prev Cardiol. 2016 Sep;23(14):1476-85. doi: 10.1177/2047487316634883. Epub 2016 Feb 23. |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestation | Previous number of pregnancies | Mean | Standard Deviation | pregnancies |
|
| Gestation age in weeks | Mean | Standard Deviation | weeks |
|
| OG002 | 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. |
|
|
| Primary | Morphine Milligram Equivalents (MME) | Morphine milligram equivalents | Posted | Mean | Standard Deviation | Morphine milligram equivalents | 48 hours |
|
|
|
| Primary | Morphine Milligram Equivalents (MME) | Morphine milligram equivalents | Posted | Mean | Standard Deviation | Morphine milligram equivalents | 72 hours |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 24 hours, 48 hours, 72 hours |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. | 0 | 60 | 0 | 60 | 0 | 60 |
| EG002 | 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. | 0 | 63 | 0 | 63 | 0 | 63 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011239 | Prednisolone |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
|
| 72 hours |
|