Cesarean Section ComplicationsPhase 4OBLiBupiNCT04897841
Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control
A Phase 4 study testing Liposomal bupivacaine, Bupivacaine Hydrochloride and saline in people with Cesarean Section Complications and Pain, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Pain, Opioid Use
- What is being tested?
- Liposomal bupivacaine, Bupivacaine Hydrochloride and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 13 Oct 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Unity-Point Health Meriter
Madison, Wisconsin, 53715
About this study
Official title: 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.
Read the 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.
- Conditions
- Cesarean Section Complications, Pain, Opioid Use
- Being tested
- Liposomal bupivacaine, Bupivacaine Hydrochloride, saline
- Keywords
- cesarean
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
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.
Bupivacaine HydrochlorideDrug
30 mL bupivacaine hydrochloride 0.25 percent, local post-surgical anesthetic
salineOther
post-surgical saline
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride; Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 48 hours postpartum
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: up to 7 days postpartum
Total Dose of Opioids in Oral Morphine Equivalents
Measured: at 12, 24, 72 hours postpartum and entire hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start11 Oct 2021
- Primary completion31 Aug 2022
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Meriter Foundation
- Responsible party
- Sponsor
- Investigators
- Kathleen M Antony, MD, MSCI, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897841
- Sponsor's protocol ID
- UPH-Meriter IRB 2021-005
- Other IDs
- A532860, SMPH/OBSTET & GYNECOL, Protocol Version 6/13/2022, 2021-0410
- Acronym
- OBLiBupi
- Status last verified
- Oct 2023
- First submitted
- 18 May 2021
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38154599
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetric Liposomal Bupivacaine Via Surgical Transversus Abdominis Plane Block for Post Cesarean Pain Control: a Single-blind Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04897841
- Acronym / sponsor ID
- OBLiBupi / UPH-Meriter IRB 2021-005
- Conditions
- Cesarean Section Complications, Pain, Opioid Use
- Keywords
- cesarean
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Meriter Foundation
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Posted 30 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control arm | Placebo comparator | Drug: Bupivacaine Hydrochloride, Other: salineThe 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). |
| Intervention: liposomal bupivacaine | Experimental | Drug: Liposomal bupivacaine, Drug: Bupivacaine Hydrochloride, Other: salineThe 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal bupivacaine20 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. | Drug | Intervention: liposomal bupivacaine |
| Bupivacaine Hydrochloride30 mL bupivacaine hydrochloride 0.25 percent, local post-surgical anesthetic | Drug | Intervention: liposomal bupivacaine, control arm |
| salinepost-surgical saline | Other | Intervention: liposomal bupivacaine, control arm |
Primary outcome
Total Opioid Usage in Oral Morphine Equivalents
Time frame: up to 48 hours postpartum
Compared via Student's t-test or Mann-Whitney U test if the distribution is non-normally distributed
7 secondary outcomes
Median Post-operative Pain Scores Measured on NRS
Time frame: Collected per standard of care every 4-6 hours up to 24 hours postpartum
Maximum Post-operative Pain Scores Measured on NRS
Time frame: Collected per standard of care every 4-6 hours up to 24 hours postpartum
Minimum Post-operative Pain Scores Measured on NRS
Time frame: Collected per standard of care every 4-6 hours up to 24 hours postpartum
Incidence of Opioid Side Effects
Time frame: up to 7 days postpartum
Percentage of Participants With Adverse Events
Time frame: up to 7 days postpartum
Time to First Rescue Analgesic Medication
Time frame: up to 7 days postpartum
Total Dose of Opioids in Oral Morphine Equivalents
Time frame: at 12, 24, 72 hours postpartum and entire hospital stay
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38154599Antony 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.
- Individual participant dataSharing planned: No
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Antony, MD, MSCI principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal bupivacaine, Bupivacaine Hydrochloride and saline in people with Cesarean Section Complications and Pain, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Opioid Usage in Oral Morphine Equivalents (time frame: up to 48 hours postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04897841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.