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

Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control: a Single-blind Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain; Cesarean Section Complications; Opioid Use
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride; Other: saline; Drug: Liposomal bupivacaine

Detailed Description

The purpose of this study is to determine whether liposomal bupivacaine administered via surgical TAP block at the time of Cesarean delivery will reduce the total dose of opioids received. The hypothesis is that liposomal bupivacaine will reduce the total dose of opioids received in the immediate 48 hours post-delivery.

Secondary outcomes will include participant self-reported pain scores, participant-reported incidence of side effects, and development of objective complications such as dysrhythmias. Other outcomes collected will include length of stay, time to first rescue analgesic medication, total dose of opioids at 12, 24, 36, 72 hours and during the hospital stay, use of supplemental oxygen during hospitalization, breastfeeding rates, both exclusive and in combination with formula use, amount of opioid prescribed at discharge and whether refills were requested or administered, rates of chronic pain at six weeks postpartum, and six week Edinburgh Depression Screen scores. Neonatal outcomes such as fetal weight, five-minute Apgar scores and development of adverse outcomes such as neonatal intensive care unit (NICU) admission will also be collected because NICU admission can impact maternal opioid use.

Primary Objective:

• To determine whether liposomal bupivacaine administered via surgical TAP block at the time of cesarean delivery will reduce the total dose of opioids received in the first 48 hours after surgery.
• Hypothesis: The hypothesis is that liposomal bupivacaine administered via surgical TAP block at the time of cesarean delivery will reduce the total dose of opioids received in the first 48 hours after surgery.
• Developmental Sub Aim: If liposomal bupivacaine administered via surgical TAP block does reduce the total dose of opioids received, to determine the degree of the reduction in order to allow for an adequately powered randomized-controlled trial.

Secondary Objective:

• To determine whether liposomal bupivacaine administered via surgical TAP block at the time of cesarean delivery will reduce patient-reported pain scores and opioid-related side effects, including respiratory compromise.
• Hypothesis: The hypothesis is that liposomal bupivacaine administered via surgical TAP block at the time of cesarean will reduce patient-reported pain scores and opioid related side effects.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Unity-Point Health Meriter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• Cardiac disease or arrhythmia: Defined as ischemic heart disease, peripartum cardiomyopathy, heart failure (with reduced or preserved ejection fraction, compensated or decompensated). Patients with a remote history of non-cyanotic pediatric cardiac surgery (like a VSD closure or PDA ligation as a child) do not need to be excluded. History of adult cardiac surgery without ongoing problems or treatments other than chronic anticoagulation (mitral valve repair for MVP or aortic valve replacement for bicuspid aortic valve for example) would not need to be excluded. History of repaired congenital cyanotic heart disease should be considered for exclusion, ultimately up to the anesthesiologist that day. A patient with a history of arrhythmias not requiring medication or ablation would NOT need to be excluded and could be included in the study. History of ablation or active anti-arrhythmic medication should be considered for exclusion.
• Hypoxia: Defined as requiring supplemental oxygen during the day.
• Acidosis. This will be uncommon in our population, but if someone has active diabetic ketoacidosis will exclude.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control arm; 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; 30 mL bupivacaine hydrochloride 0.25 percent, local post-surgical anesthetic; Other: saline; post-surgical saline
Experimental: Intervention: liposomal bupivacaine; 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: Bupivacaine Hydrochloride; 30 mL bupivacaine hydrochloride 0.25 percent, local post-surgical anesthetic; Other: saline; post-surgical saline; Drug: Liposomal bupivacaine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Post-operative Pain Scores Measured on NRS	Numeric rating scale (NRS) which rates pain on a 0-10 scale where 10 is increased pain.	Collected per standard of care every 4-6 hours up to 24 hours postpartum
Maximum Post-operative Pain Scores Measured on NRS	Numeric rating scale (NRS) which rates pain on a 0-10 scale where 10 is increased pain.	Collected per standard of care every 4-6 hours up to 24 hours postpartum
Minimum Post-operative Pain Scores Measured on NRS	Numeric rating scale (NRS) which rates pain on a 0-10 scale where 10 is increased pain.	Collected per standard of care every 4-6 hours up to 24 hours postpartum
Incidence of Opioid Side Effects	Number of patients reporting opioid-related side effects, such as pruritis, constipation, nausea, and mental clouding.	up to 7 days postpartum
Percentage of Participants With Adverse Events	Percentage of complications of bupivacaine, such as local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, arrhythmias, methemoglobinemia, and allergies and hypersensitivities	up to 7 days postpartum
Time to First Rescue Analgesic Medication	Time to first rescue analgesic medication, measured in minutes from arrival in the post-anesthesia care unit (PACU) until the first as needed opioid dose is administered.	up to 7 days postpartum
Total Dose of Opioids in Oral Morphine Equivalents		at 12, 24, 72 hours postpartum and entire hospital stay

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Breastfeeding at Hospital Discharge	Breastfeeding rates, both exclusive and breastfeeding with supplementation at the time of discharge	up to 7 days postpartum
Fetal Weight		at birth
Five-minute Apgar Scores	The Apgar Score is a measure of fetal health status immediately after birth. It comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2 for a total possible score of 0-10, where higher scores indicate better health.	5 minutes after birth
Number of Participants Readmitted to the Hospital		up to 6 weeks postpartum
Length of Postpartum Hospital Stay		up to 7 days postpartum
Incidence of Supplemental Oxygen Use During Hospitalization	Number of participants requiring supplemental oxygen use	up to 7 days postpartum
Amount of Opioid Prescribed at Discharge		up to 7 days postpartum
Percentage of Participants With Opioid Refills Requested		6 weeks postpartum
Number of Opioid Pills Used		6 weeks postpartum
Postnatal Depression Screen	Participants self-reported feeling down or depressed	6 weeks postpartum
Percentage of Participants Who Would Recommend Treatment	2 weeks postpartum, participants will be asked to report whether they would recommend the treatment they received	2 weeks postpartum
6 Week Postpartum Satisfaction Survey Response Percentage	6 weeks postpartum, participants will be asked whether they would recommend the treatment they received.	6 weeks postpartum
Number of Participants With at Least One Newborn Admitted to the Neonatal Intensive Care Unit (NICU)	NICU admission is a potential confounding variable for maternal opioid use.	up to 7 days postpartum

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Meriter Foundation
• Investigators: Principal Investigator: Kathleen M Antony, MD, MSCI, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): October 13, 2022

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cesarean
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: UPH-Meriter IRB 2021-005; A532860 (Other Identifier: UW Madison); SMPH/OBSTET & GYNECOL (Other Identifier: UW Madison); 2021-0410 (Other Identifier: M D Anderson Cancer Center); Protocol Version 6/13/2022 (Other Identifier: Meriter IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: Yes