Efficacy of Extended-Release Liposomal Bupivacaine for Post-Partum Pain Management Following Obstetrical Laceration
Public ClinicalTrials.gov record NCT03152877. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Efficacy of Extended-Release Liposomal Bupivacaine for Post-Partum Pain Management Following Obstetrical Laceration: A Prospective, Randomized, Single-Blinded Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
We propose a prospective, randomized, single blinded trial with subjects recruited from the WRNMMC Labor and Delivery Unit to study post-partum efficacy of Exparel® for pain control in patients undergoing a vaginal delivery who sustained a second, third, or fourth degree obstetrical laceration. Subjects who meet inclusion criteria and agree to participate in the study will be consented upon admission for active labor or induction of labor and will be randomized to receive either 20mL of liposomal bupivacaine or 20ml of 0.25% plain bupivacaine, infiltrated through the perineum at completion of their obstetrical repair. Current standard of care is to receive no injection of local anesthetic upon completion of the repair. The primary aim of the trial will be to evaluate post-partum pain using a visual analogue pain scale at days 1, 3 and 7 postpartum. All subjects will have acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control regardless of assignment, which is the usual post-partum pain control regimen. We anticipate a 30% difference in post-operative pain measurements between the Exparel® group and the plain bupivacaine group. Other aims of this study are to evaluate total medication usage, comparing the study group to the control, and compare quality of life measures between the two study groups.
Study identification
- NCT ID
- NCT03152877
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2018
- Primary completion
- Feb 28, 2019
- Completion
- Feb 28, 2019
- Last update posted
- Jul 14, 2019
2018 – 2019
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20814 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03152877, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2019 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03152877 live on ClinicalTrials.gov.