- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04393207
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
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).
Study Overview
Status
Conditions
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)
- 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Antonio Gonzalez, MD
- Phone Number: 4133869415
- Email: Antonio.Gonzalez-fiol@yale.edu
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06510
- Recruiting
- Yale University
-
Contact:
- Antonio Gonzalez, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients between the ages of 18 and 45 presenting for cesarean delivery
- ASA-1, ASA-2, ASA-3
- No allergy to morphine
- No allergy to bupivacaine
- Patients with BMI > 45 will be excluded
- No history of anxiety
- No recent or chronic opioid use
Exclusion Criteria:
- Need for Magnesium sulfate therapy
- Neonatal admission to neonatal intensive care unit
- Need for additional surgery other than cesarean delivery +/- bilateral tubal ligation (e.g. hysterectomy, cystotomy)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group (Bupivacaine)
Patient will receive intrathecal morphine and TAP block with plain bupivacaine.
|
Transverse abdominis plane block will be performed with plain bupivacaine
Other Names:
|
Experimental: Liposomal Bupivacaine
Patient will receive intrathecal morphine + TAP block with Liposomal bupivacaine and bupivacaine 0.25%
|
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.
Other Names:
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.
Other Names:
|
Active Comparator: Bupivacaine + dexamethasone and methylprednisolone
Patient will receive intrathecal morphine + TAP block with only bupivacaine.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MME
Time Frame: 24 hours
|
Morphine milligram equivalents
|
24 hours
|
MME
Time Frame: 48 hours
|
Morphine milligram equivalents
|
48 hours
|
MME
Time Frame: 72 hours
|
Morphine milligram equivalents
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of functional recovery
Time Frame: 6 hours
|
Number of steps after delivery
|
6 hours
|
Assessment of functional recovery
Time Frame: 12 hours
|
Number of steps after delivery
|
12 hours
|
Assessment of functional recovery
Time Frame: 24 hours
|
Number of steps after delivery
|
24 hours
|
Assessment of functional recovery
Time Frame: 36 hours
|
Number of steps after delivery
|
36 hours
|
Assessment of functional recovery
Time Frame: 48 hours
|
Number of steps after delivery
|
48 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self assessed recovery survey
Time Frame: 24 hours
|
Use of a validated questionnaire to measure recovery after cesarean delivery ObsQoR-11
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Antonio Gonzalez, MD, Yale University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Acute Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Neuroprotective Agents
- Protective Agents
- Anesthetics, Local
- Dexamethasone
- Dexamethasone acetate
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- BB 1101
- Bupivacaine
Other Study ID Numbers
- 2000027606
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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