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NCT03152877 · ClinicalTrials.gov registry record · NA
Efficacy of Extended-Release Liposomal Bupivacaine for Post-Partum Pain Management Following Obstetrical Laceration
A NA study, sponsored by Walter Reed National Military Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT03152877: Completed NA study, sponsored by Walter Reed National Military Medical Center.
NCT03152877 is a NA study that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 120 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03152877, a NA study, has completed, sponsored by Walter Reed National Military Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The primary goal of the study is to assess how effective the study medication is in providing adequate pain control following repair of a second, third, or fourth degree laceration; therefore, the subjects' post-partum pain will be assessed at various intervals following the repair. On post-partum day one, subjects will be asked questions regarding their pain level in the vaginal area according to the Defense and Veterans Pain Rating Scale, which is an 11-point visual analog pain scale.
Interventions
- DRUG Bupivacaine Liposome Injectable Product
- DRUG 0.25% plain bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2019-03-01 |
| Phase | NA |
What the finished NCT03152877 record still lists
NCT03152877 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Bupivacaine Liposome Injectable Product is the first listed.
NCT03152877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03152877 about?
NCT03152877 is a clinical study titled "Efficacy of Extended-Release Liposomal Bupivacaine for Post-Partum Pain Management Following Obstetrical Laceration". 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. Subj...
What is the current status of trial NCT03152877?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2018-03-01. Estimated completion is 2019-03-01.
What interventions are being tested in trial NCT03152877?
The interventions under investigation include: Bupivacaine Liposome Injectable Product (DRUG), 0.25% plain bupivacaine (DRUG).
Who is sponsoring clinical trial NCT03152877?
This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03152877's enrollment target sits among peer trials
120 762nd of 2000 higher than 1,198 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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