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NCT04388111 · ClinicalTrials.gov registry record · Phase 4
Intraosseous Morphine in Primary TKA
A Phase 4 study, sponsored by The Methodist Hospital Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 65
- Enrollment target
NCT04388111 is a Phase 4 study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 65 participants.
The verdict
NCT04388111, a Phase 4 study, has completed, sponsored by The Methodist Hospital Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 65 participants
- Enrollment target
Study Summary
The research team wants to investigate if an intraosseous injection (directly into the bone marrow) of morphine during primary total knee replacement helps with post-operative pain following primary total knee replacement surgery. For this study patients will either be randomized into one of two groups: Group 1: Receives an intraosseous injection of morphine (mixed with standard antibiotics) during their primary total knee replacement or Group 2: Serves as the control group and only receives an intraosseous injection of antibioitics during their total knee replacement. The research team will have patients fill out a symptom journal for two weeks following their surgery to measure pain levels and pain medication consumed throughout the day as well as nausea and other symptoms. Additionally, the research team will take blood samples both intraoperatively and post-operatively (10 hours post-op) to measure the level of inflammatory markers as well as morphine.
Interventions
- DRUG Morphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2020-05-05 |
| Est. Completion | 2021-05-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04388111
The ClinicalTrials.gov registry entry for NCT04388111 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Methodist Hospital Research Institute, which has 126 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Morphine is the first listed.
NCT04388111 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04388111 about?
NCT04388111 is a clinical study titled "Intraosseous Morphine in Primary TKA". The research team wants to investigate if an intraosseous injection (directly into the bone marrow) of morphine during primary total knee replacement helps with post-operative pain following primary total knee replacement surgery. For this study patients will either be randomized into one of two gro...
What is the current status of trial NCT04388111?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 65 participants. The study started on 2020-05-05. Estimated completion is 2021-05-31.
What interventions are being tested in trial NCT04388111?
The interventions under investigation include: Morphine (DRUG).
Who is sponsoring clinical trial NCT04388111?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
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