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NCT02922985 · ClinicalTrials.gov registry record · Phase 4
Multimodal Pain Management for Cesarean Delivery
A Phase 4 study, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
NCT02922985 is a Phase 4 study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 120 participants.
The verdict
NCT02922985, a Phase 4 study, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
Study Summary
Opioid use and abuse has become a major medical problem in the United States. Over prescription of opioid medications is a major contributor to this growing problem. Cesarean delivery (CD) is the most commonly performed surgery in the US and women are generally given opioid medications for postoperative pain management. This is not a common practice in other developed countries. We believe that a multimodal pain management strategy is superior to current practices for control of postoperative pain after CD and will lead to a decrease in the use of opioid medications. This will have beneficial effects on patients' recovery and bonding with their newborns, as well as societal effects in reducing the burden of opioid abuse in the US. Our objective is to investigate the use of a multimodal pain regimen in pregnant patients undergoing CD. This is a randomized double-blinded, placebo controlled trial. The multimodal intervention consists of a pre-operative dose of IV acetaminophen (Ofirmev), infiltration of subcutaneous bupivacaine prior to skin incision, and a dose of IM ketorolac at time of fascial closure. These study medications are currently used in our patient population but not in a standardized fashion, not in every patient, and not always in combination with each other. The control group will receive placebo IV infusion preoperatively and an IM injection at fascial closure, and subcutaneous infiltration with normal saline before skin incision. Both groups will receive spinal regional anesthesia as per anesthesia team and then postoperatively, both groups will receive the current standard of care, which consists postoperative hydrocodone/acetaminophen and ibuprofen as needed depending on pain score. Our primary outcome of interest will be the total opioid intake in the first 48 hours after surgery. Secondary outcomes include time to first opioid given, pain scores at 6-12, 24 and 48 hours post op, and total number of opioid tablets left after discharge on post op
Interventions
- DRUG Normal saline
- DRUG Intravenous acetominophen
- DRUG Ketorolac, intramuscular
- DRUG Bupivacaine, subcutaneous
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2016-10 |
| Est. Completion | 2017-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02922985
The ClinicalTrials.gov registry entry for NCT02922985 describes a study currently listed as completed, categorized as Phase 4. 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 The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Normal saline is the first listed.
NCT02922985 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02922985 about?
NCT02922985 is a clinical study titled "Multimodal Pain Management for Cesarean Delivery". Opioid use and abuse has become a major medical problem in the United States. Over prescription of opioid medications is a major contributor to this growing problem. Cesarean delivery (CD) is the most commonly performed surgery in the US and women are generally given opioid medications for postopera...
What is the current status of trial NCT02922985?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2016-10. Estimated completion is 2017-07.
What interventions are being tested in trial NCT02922985?
The interventions under investigation include: Normal saline (DRUG), Intravenous acetominophen (DRUG), Ketorolac, intramuscular (DRUG), Bupivacaine, subcutaneous (DRUG).
Who is sponsoring clinical trial NCT02922985?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
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