Status:
COMPLETED
Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Meriter Foundation
Conditions:
Cesarean Section Complications
Pain
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 cumulativ...
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 hypothe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04897841
Start Date
October 11 2021
End Date
October 13 2022
Last Update
August 22 2025
Active Locations (1)
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1
Unity-Point Health Meriter
Madison, Wisconsin, United States, 53715