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NCT03383588 · ClinicalTrials.gov registry record · Phase 2
Subcutaneous Bupivacaine Decrease Post-op Pain in Patients Undergoing C-Section
A Phase 2 study, sponsored by Montefiore Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT03383588 is a Phase 2 study that was terminated before completion, run by Montefiore Medical Center. The registered enrollment target is 26 participants.
The verdict
NCT03383588, a Phase 2 study, was terminated before completion, sponsored by Montefiore Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if giving an injection of numbing medication at the incision at the end of cesarean will help control pain AFTER cesarean delivery. This study seeks to assess pain relief with incisional infiltration of local anesthetic during cesareans performed under spinal anesthesia also using intrathecal opioids. Participants will receive the usual regimen of pain medication in spinal anesthesia. At the end of the cesarean delivery, while the participants are still under the spinal medication, participants will receive an injection, at the incision, either numbing medication (with or without epinephrine) or sterile saline. After the cesarean delivery, participants will receive, by mouth, commonly prescribed pain medications - these medications are oxycodone (an opioid/ narcotic), acetaminophen (or more commonly known as Tylenol), and ibuprofen.
Interventions
- DRUG Bupivacaine
- DRUG Epinephrine
- DRUG Morphine
- DRUG Fentanyl
- OTHER Saline solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2018-07-19 |
| Est. Completion | 2018-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03383588
The ClinicalTrials.gov registry entry for NCT03383588 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Bupivacaine is the first listed.
NCT03383588 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03383588 about?
NCT03383588 is a clinical study titled "Subcutaneous Bupivacaine Decrease Post-op Pain in Patients Undergoing C-Section". The purpose of this study is to determine if giving an injection of numbing medication at the incision at the end of cesarean will help control pain AFTER cesarean delivery. This study seeks to assess pain relief with incisional infiltration of local anesthetic during cesareans performed under spina...
What is the current status of trial NCT03383588?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2018-07-19. Estimated completion is 2018-12-31.
What interventions are being tested in trial NCT03383588?
The interventions under investigation include: Bupivacaine (DRUG), Epinephrine (DRUG), Morphine (DRUG), Fentanyl (DRUG), Saline solution (OTHER).
Who is sponsoring clinical trial NCT03383588?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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