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

Primary Purpose

Opioid Use, Pain, Acute

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal bupivacaine (LB)
Dexamethasone and methylprednisolone (CG)
Control group (Bupivacaine)- (BPG)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Opioid Use

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Yale UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Control group (Bupivacaine)

Liposomal Bupivacaine

Bupivacaine + dexamethasone and methylprednisolone

Arm Description

Patient will receive intrathecal morphine and TAP block with plain bupivacaine.

Patient will receive intrathecal morphine + TAP block with Liposomal bupivacaine and bupivacaine 0.25%

Patient will receive intrathecal morphine + TAP block with only bupivacaine.

Outcomes

Primary Outcome Measures

MME
Morphine milligram equivalents
MME
Morphine milligram equivalents
MME
Morphine milligram equivalents

Secondary Outcome Measures

Assessment of functional recovery
Number of steps after delivery
Assessment of functional recovery
Number of steps after delivery
Assessment of functional recovery
Number of steps after delivery
Assessment of functional recovery
Number of steps after delivery
Assessment of functional recovery
Number of steps after delivery

Full Information

First Posted
May 13, 2020
Last Updated
February 14, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT04393207
Brief Title
TAP Block Using Liposomal Bupivacaine for Post-cesarean Delivery Analgesia- Walking Towards Recovery
Official Title
Transverse Abdominis Plane Block Using Liposomal Bupivacaine for Post-operative Cesarean Delivery Analgesia- Walking Towards Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Pain, Acute

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group (Bupivacaine)
Arm Type
Active Comparator
Arm Description
Patient will receive intrathecal morphine and TAP block with plain bupivacaine.
Arm Title
Liposomal Bupivacaine
Arm Type
Experimental
Arm Description
Patient will receive intrathecal morphine + TAP block with Liposomal bupivacaine and bupivacaine 0.25%
Arm Title
Bupivacaine + dexamethasone and methylprednisolone
Arm Type
Active Comparator
Arm Description
Patient will receive intrathecal morphine + TAP block with only bupivacaine.
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine (LB)
Other Intervention Name(s)
Exparel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone and methylprednisolone (CG)
Other Intervention Name(s)
Dexamethasone and methylprednisolone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Control group (Bupivacaine)- (BPG)
Other Intervention Name(s)
Sensorcaine, Marcaine
Intervention Description
Transverse abdominis plane block will be performed with plain bupivacaine
Primary Outcome Measure Information:
Title
MME
Description
Morphine milligram equivalents
Time Frame
24 hours
Title
MME
Description
Morphine milligram equivalents
Time Frame
48 hours
Title
MME
Description
Morphine milligram equivalents
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Assessment of functional recovery
Description
Number of steps after delivery
Time Frame
6 hours
Title
Assessment of functional recovery
Description
Number of steps after delivery
Time Frame
12 hours
Title
Assessment of functional recovery
Description
Number of steps after delivery
Time Frame
24 hours
Title
Assessment of functional recovery
Description
Number of steps after delivery
Time Frame
36 hours
Title
Assessment of functional recovery
Description
Number of steps after delivery
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
Self assessed recovery survey
Description
Use of a validated questionnaire to measure recovery after cesarean delivery ObsQoR-11
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Gonzalez, MD
Phone
4133869415
Email
antonio.gonzalez-fiol@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Gonzalez, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Gonzalez, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24012493
Citation
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.
Results Reference
background
PubMed Identifier
21498494
Citation
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.
Results Reference
background
PubMed Identifier
30573987
Citation
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.
Results Reference
background
PubMed Identifier
23433933
Citation
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.
Results Reference
background
PubMed Identifier
26907794
Citation
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.
Results Reference
background

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

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