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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 is a NA study that has completed, run by Walter Reed National Military Medical Center. The registered enrollment target is 120 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03152877
The ClinicalTrials.gov registry entry for NCT03152877 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Walter Reed National Military Medical Center, which has 48 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bupivacaine Liposome Injectable Product is the first listed.
NCT03152877 reports 0 study locations.
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.
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