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NCT02067520 · ClinicalTrials.gov registry record · Phase 4
Intrathecal Hydromorphone for Cesarean Section
A Phase 4 study of Pain, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 4
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT02067520 is a Phase 4 study of Pain that has completed, run by Thomas Jefferson University. The registered enrollment target is 54 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02067520, a Phase 4 study of Pain, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
Introduction: Cesarean section (C/S) is usually performed under spinal with preservative free morphine for pain relief, but the investigators have a severe shortage of this formulation of morphine. Hydromorphone is a narcotic which acts peripherally and centrally to decrease pain. It has been used in spinals for postoperative pain relief and in pain pumps for relief of chronic pain. No randomized controlled studies have evaluated intrathecal (IT) hydromorphone for post C/S pain. Methods: This is a randomized double-blind controlled trial utilizing the up-down sequential allocation method1,2 to find the best dose of IT hydromorphone that provides pain relief following C/S. Patients will be given a morphine PCA pump for additional pain relief. Our first patient will receive 200 mcg of IT hydromorphone. Pain, nausea, and itching will be evaluated at 4, 8, 12 and 24 hours following the C/S via numeric rating scales; vomiting and morphine use per hour will be recorded. Success will be a median morphine usage of less than or equal to 1mg/hour in the following 16 hours. If a success, the next patient will be given 10 mcg less IT hydromorphone; if a failure, she will receive 10 mcg more. The study will end after 5 successes. Objective: The primary objective is to find the optimal dose of IT hydromorphone for pain relief following C/S. The secondary objectives are to define the incidence and severity of hydromorphone's side effects and determine the duration of analgesia.
Conditions Studied
Interventions
- DRUG intrathecal hydromorphone (IT hydromorphone)
Study Locations (1)
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02067520
The ClinicalTrials.gov registry entry for NCT02067520 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (82% lower). The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pain appearing as the primary indexed condition, and to 1 intervention - of which intrathecal hydromorphone (IT hydromorphone) is the first listed.
NCT02067520 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02067520 about?
NCT02067520 is a clinical study titled "Intrathecal Hydromorphone for Cesarean Section". Introduction: Cesarean section (C/S) is usually performed under spinal with preservative free morphine for pain relief, but the investigators have a severe shortage of this formulation of morphine. Hydromorphone is a narcotic which acts peripherally and centrally to decrease pain. It has been used ...
What is the current status of trial NCT02067520?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 54 participants. The study started on 2014-01. Estimated completion is 2015-06.
What conditions does trial NCT02067520 study?
This clinical trial studies the following conditions: Pain.
What interventions are being tested in trial NCT02067520?
The interventions under investigation include: intrathecal hydromorphone (IT hydromorphone) (DRUG).
Who is sponsoring clinical trial NCT02067520?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02067520 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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