Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control

NCT04897841 | Completed Phase 4 Results DMC FDA Drug

• 5 other identifiers: UPH-Meriter IRB 2021-005A532860SMPH/OBSTET & GYNECOLProtocol Version 6/13/20222021-0410
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to identify whether the addition of liposomal bupivacaine to regular bupivacaine and saline administered via surgical transversus abdominis plane (TAP) block will reduce the cumulative opioid dose in the first 48 hours after cesarean. 60 women scheduled for cesarean at Unity-Point Health Meriter Hospital in Madison, Wisconsin will be enrolled and can be expect to be on study for up to 6 weeks post-partum.

Conditions

Cesarean Section Complications; Pain; Opioid Use

Keywords

cesarean

Outcome Measures

Primary Outcomes (1)

• Total Opioid Usage in Oral Morphine Equivalents

  Compared via Student's t-test or Mann-Whitney U test if the distribution is non-normally distributed

  up to 48 hours postpartum

Secondary Outcomes (7)

• Median Post-operative Pain Scores Measured on NRS

  Collected per standard of care every 4-6 hours up to 24 hours postpartum

• Maximum Post-operative Pain Scores Measured on NRS

  Collected per standard of care every 4-6 hours up to 24 hours postpartum

• Minimum Post-operative Pain Scores Measured on NRS

  Collected per standard of care every 4-6 hours up to 24 hours postpartum

• Incidence of Opioid Side Effects

  up to 7 days postpartum

• Percentage of Participants With Adverse Events

  up to 7 days postpartum

Other Outcomes (13)

• Length of Postpartum Hospital Stay

  up to 7 days postpartum

• Incidence of Supplemental Oxygen Use During Hospitalization

  up to 7 days postpartum

• Number of Participants Breastfeeding at Hospital Discharge

  up to 7 days postpartum

Study Arms (2)

control arm

PLACEBO COMPARATOR

The control arm will receive 30 mL of bupivacaine HCl plus 50 mL of saline injected into the lateral transversus abdominis plane via surgical approach (abdominal approach).

Drug: Bupivacaine Hydrochloride; Other: saline

Intervention: liposomal bupivacaine

EXPERIMENTAL

The intervention arm will receive 30 mL of bupivacaine HCl plus 30 mL of saline plus 20 mL of liposomal bupivacaine injected into the lateral transversus abdominis plane via surgical approach (abdominal approach).

Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride; Other: saline

Interventions

Liposomal bupivacaine DRUG

20 mL prior to closing fascia, the active drug (bupivacaine) is encapsulated in a liposomal platform and released slowly over the course of days with an approximate 72 hour duration.

Intervention: liposomal bupivacaine

Bupivacaine Hydrochloride DRUG

30 mL bupivacaine hydrochloride 0.25 percent, local post-surgical anesthetic

Intervention: liposomal bupivacaine; control arm

saline OTHER

post-surgical saline

Intervention: liposomal bupivacaine; control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal age greater than or equal to 18
• Singleton or multifetal pregnancy
• Able to receive neuraxial analgesia
• Planned/ scheduled Cesarean delivery OR non-urgent Cesarean delivery at UnityPoint-Health Meriter with adequate time to consider and consent to the study
• Able to provide consent in English

You may not qualify if:

• Known hypersensitivity to bupivacaine (defined as a history of a reaction or allergy to bupivacaine (injectable, intravenous, or transdermal) reported by patient or documented in the medical record
• Contraindication to regional analgesia
• Positive urine drug screen at admission to the hospital, if ordered for clinical purposes.
• Current opioid use or opioid use disorder per patient report or documented in the medical record
• Chronic opioid use or opioid use disorder, either patient reported or documented in the medical record, defined as opioid use on most days for greater than 3 months
• Planned cesarean hysterectomy (excluded due to anticipated blood loss and alternative pain control measures, possible prolonged intubation)
• Planned vertical midline incision (excluded due to possible different postpartum pain)
• Presence of renal dysfunction precluding the use of NSAIDs (NSAIDs are part of the usual postpartum pain regimen/ hospital protocol) per discretion of the treating physician or PI
• Ischemic heart disease, congestive heart failure, or cardiomyopathy of pregnancy precluding the use of NSAIDs (NSAIDs are part of the usual postpartum pain regimen/ hospital protocol) per discretion of the treating physician or PI
• Significant liver dysfunction precluding the use of acetaminophen (acetaminophen is part of the usual postpartum pain regimen/ hospital protocol) per discretion of the treating physician or PI
• Coagulopathy
• Planned discharge from the hospital less than 48 hours postpartum
• Unable to receive post-operative scheduled acetaminophen for any reason, such as allergy to acetaminophen or elevated liver function tests precluding acetaminophen use
• Unable to receive post-operative scheduled NSAIDs for any reason, such as allergy to ketorolac or ibuprofen, or renal dysfunction precluding NSAID use
• Seizure disorder: Specifically, poorly controlled seizure disorder defined as having had a seizure within the last three years despite antiepileptic use or poorly managed seizure disorder due to medication non-compliance.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Meriter Foundation: collaborator

Study Sites (1)

Unity-Point Health Meriter

Madison, Wisconsin, 53715, United States

Location

Related Publications (1)

• Antony KM, McDonald RC, Gaston L, Hetzel S, Li Z. Surgical transversus abdominis plane block with liposomal bupivacaine at cesarean: a pilot randomized trial. Am J Obstet Gynecol MFM. 2024 Feb;6(2):101273. doi: 10.1016/j.ajogmf.2023.101273. Epub 2023 Dec 26.

  PMID: 38154599 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Sharon Blohowiak
• Organization: University of Wisconsin - Madison

sblohowiak@wisc.edu

608-417-6957

Study Officials

• Kathleen M Antony, MD, MSCI

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 24, 2021
• Study Start: October 11, 2021
• Primary Completion: August 31, 2022
• Study Completion: October 13, 2022
• Last Updated: August 22, 2025
• Results First Posted: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)