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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: Completed Phase 4 study, sponsored by The Methodist Hospital Research Institute.
NCT04388111 is a Phase 4 study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 65 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Patient will fill out Visual Analog Scale pain scores three times a day for 14 days (day 1 as day of surgery) post-op in a pain journal. Levels will be compared between study groups. A higher score indicates a higher self-perceived level of pain and a lower score indicates a lower perceived level of pain for the patient. "0" representing no pain at all on the scale and "10" representing the highest pain imaginable. Scores are reported 3 times a day per day and averaged for that day. All of these
Interventions
- DRUG Morphine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2020-05-05 |
| Est. Completion | 2021-05-31 |
| Phase | Phase 4 |
What the finished NCT04388111 record still lists
NCT04388111 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Morphine is the first listed.
NCT04388111 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04388111's enrollment target sits among peer trials
65 1091st of 2000 higher than 903 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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