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

NCT04393207 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 2000027606
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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).

Conditions

Opioid Use; Pain, Acute

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

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

  24 hours, 48 hours, 72 hours

Study Arms (3)

Control group (Bupivacaine)

ACTIVE COMPARATOR

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

Drug: Control group (Bupivacaine)- (BPG)

Liposomal Bupivacaine

EXPERIMENTAL

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

Drug: Liposomal bupivacaine (LB); Drug: Dexamethasone and methylprednisolone (CG)

Bupivacaine + dexamethasone and methylprednisolone

ACTIVE COMPARATOR

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

Drug: Dexamethasone and methylprednisolone (CG)

Interventions

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.

Also known as: Exparel

Liposomal Bupivacaine

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.

Also known as: Dexamethasone and methylprednisolone

Bupivacaine + dexamethasone and methylprednisolone; Liposomal Bupivacaine

Control group (Bupivacaine)- (BPG) DRUG

Transverse abdominis plane block will be performed with plain bupivacaine

Also known as: Sensorcaine, Marcaine

Control group (Bupivacaine)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

Related Publications (5)

• 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.

  PMID: 24012493 BACKGROUND

• 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.

  PMID: 21498494 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.

  PMID: 30573987 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.

  PMID: 23433933 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.

  PMID: 26907794 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Dexamethasone; Methylprednisolone; Control Groups; Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Prednisolone; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Antonio Gonzalez
• Organization: Yale

antonio.gonzalez-fiol@yale.edu

203.785.2802

Study Officials

• Antonio Gonzalez, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 19, 2020
• Study Start: February 1, 2022
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)