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NCT01943565 · ClinicalTrials.gov registry record · Phase 4
Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 29
- Enrollment target
NCT01943565: Clinical Trial Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT01943565 is a Phase 4 study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 29 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01943565, a Phase 4 study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 29 participants
- Enrollment target
Study Summary
Pain relief after cesarean delivery can be provided in a few ways. Most commonly, certain medications called opioids, such as morphine, are given through the vein or into the muscle. However, a more effective way to give pain relief with fewer side effects (such as nausea and slowing your breathing) is to give opioids in the spinal space as part of the medications given for a cesarean delivery. For many years, the opioid of choice was morphine due to its long anesthetic effect and acceptable side effect profile. A nation-wide disruption in the supply of preservative-free morphine has made it necessary to look for alternatives. Many institutions worldwide have used another opioid, called hydromorphone, in the spinal space for over a decade. This drug has a very good safety and side effect profile and has been used at the investigators' institution for more than a year. Of interest, while a number of different doses of hydromorphone have been used, there have been very few studies to evaluate the best dose for providing good pain relief with minimal side effects. The goal of this study is to find the best dose of spinal hydromorphone for women undergoing cesarean delivery.
Primary Outcome
Intrathecal (IT) hydromorphone added to intrathecally administered local anesthetics for spinal anesthesia increases patient comfort by decreasing post-operative pain. This leads to a decrease in the post-operative intravenous hydromorphone requirements.
Interventions
- DRUG Hydromorphone 25mcg
- DRUG Hydromorphone 50mcg
- DRUG Hydromorphone 100mcg
- DRUG spinal anesthesia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2014-12 |
| Est. Completion | 2016-08 |
| Phase | Phase 4 |
Why NCT01943565 stopped before completion
NCT01943565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 4 interventions - of which Hydromorphone 25mcg is the first listed.
NCT01943565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01943565 about?
NCT01943565 is a clinical study titled "Intrathecal Hydromorphone for Post-cesarean Delivery Pain - a Dose Finding Study". Pain relief after cesarean delivery can be provided in a few ways. Most commonly, certain medications called opioids, such as morphine, are given through the vein or into the muscle. However, a more effective way to give pain relief with fewer side effects (such as nausea and slowing your breathing)...
What is the current status of trial NCT01943565?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 29 participants. The study started on 2014-12. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01943565?
The interventions under investigation include: Hydromorphone 25mcg (DRUG), Hydromorphone 50mcg (DRUG), Hydromorphone 100mcg (DRUG), spinal anesthesia (DRUG).
Who is sponsoring clinical trial NCT01943565?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01943565's enrollment target sits among peer trials
29 1634th of 2000 higher than 366 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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