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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: Completed Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.
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 |
What the finished NCT02096003 record still lists
NCT02096003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Intrathecal morphine is the first listed.
NCT02096003 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02096003's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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