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NCT02787928 · ClinicalTrials.gov registry record · Phase 1
Dose and Response of Intrathecal Hydromorphone in Patients Undergoing Cesarean Section at Virginia Commonwealth University Health System
A Phase 1 study, sponsored by Virginia Commonwealth University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02787928 is a Phase 1 study that was terminated before completion, run by Virginia Commonwealth University. The registered enrollment target is 14 participants.
The verdict
NCT02787928, a Phase 1 study, was terminated before completion, sponsored by Virginia Commonwealth University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
In the United States the incidence of cesarean deliveries have increased over the last several decades and is currently approximately 30% nationwide. The anesthesia and analgesia for elective c-sections vary between institutions. Parturients present a unique challenge for the anesthesiologist as the mother has to care not only for herself, but also for the newborn postpartum. While intrathecal opioids provide adequate pain relief, they do so at the cost of bothersome side effects for patients, such as pruritus and nausea/vomiting. Intrathecal hydromorphone has started to be explored as a new option for intrathecal analgesia. A study done by Beatty et al. showed in a retrospective review that 40 mcg of intrathecal dilaudid was safe and effective as compared to intrathecal morphine for analgesia after cesarean delivery. Additionally they showed no difference in side effect profiles of the two medications. Mhyre et al. investigated the use of 100 mcg of intrathecal dilaudid with hyperbaric bupivacaine in varying dosages for labor analgesia. The results were inconclusive, but the dosage of hydromorphone was reported to be without adverse effects. Virginia Commonwealth University Health Systems has successfully instituted the use of intrathecal morphine with superior analgesia but with undesired side effects, most notably pruritus. Recent drug shortages of duramorph have prompted investigators to seek alternative options for post cesarean section analgesia. The investigators are interested in determining the dose, efficacy, and side effect profile of intrathecal hydromorphone. Although our institution has never utilized intrathecal hydromorphone for our patient population, it has been studied at various other institutions where it has been found to be safe and efficacious with an acceptable side effect profile.
Interventions
- DRUG Intrathecal hydromorphone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2016-04 |
| Est. Completion | 2017-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02787928
The ClinicalTrials.gov registry entry for NCT02787928 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Intrathecal hydromorphone is the first listed.
NCT02787928 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02787928 about?
NCT02787928 is a clinical study titled "Dose and Response of Intrathecal Hydromorphone in Patients Undergoing Cesarean Section at Virginia Commonwealth University Health System". In the United States the incidence of cesarean deliveries have increased over the last several decades and is currently approximately 30% nationwide. The anesthesia and analgesia for elective c-sections vary between institutions. Parturients present a unique challenge for the anesthesiologist as th...
What is the current status of trial NCT02787928?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2016-04. Estimated completion is 2017-12-31.
What interventions are being tested in trial NCT02787928?
The interventions under investigation include: Intrathecal hydromorphone (DRUG).
Who is sponsoring clinical trial NCT02787928?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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