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NCT02096003 · ClinicalTrials.gov registry record · Phase 2
Intrathecal Hydromorphone for Pain Control After Cesarean Section
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT02096003 is a Phase 2 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 80 participants.
The verdict
NCT02096003, a Phase 2 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery. Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting. Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section. In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. The investigators need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.
Interventions
- DRUG Intrathecal morphine
- DRUG Intrathecal hydromorphone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-05-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02096003
The ClinicalTrials.gov registry entry for NCT02096003 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intrathecal morphine is the first listed.
NCT02096003 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02096003 about?
NCT02096003 is a clinical study titled "Intrathecal Hydromorphone for Pain Control After Cesarean Section". The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce...
What is the current status of trial NCT02096003?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2014-05. Estimated completion is 2017-05-05.
What interventions are being tested in trial NCT02096003?
The interventions under investigation include: Intrathecal morphine (DRUG), Intrathecal hydromorphone (DRUG).
Who is sponsoring clinical trial NCT02096003?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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