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NCT04003350 · ClinicalTrials.gov registry record · NA
The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
A NA study, sponsored by Rothman Institute Orthopaedics.
- Completed
- Registry status
- NA
- Development phase
- 216
- Enrollment target
NCT04003350: Completed NA study, sponsored by Rothman Institute Orthopaedics.
NCT04003350 is a NA study that has completed, run by Rothman Institute Orthopaedics. The registered enrollment target is 216 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04003350, a NA study, has completed, sponsored by Rothman Institute Orthopaedics.
- COMPLETED
- Registry status
- NA
- Development phase
- 216 participants
- Enrollment target
Study Summary
It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. This multimodal analgesic regimen also leads to reduce opioid consumption and its related side effects after hip and knee joint replacement procedures. One potential strategy to reduce the use of opioids after TKA is to administer a prolonged oral multimodal pain regimen that targets multiple pain pathways in the post hospital discharge period. This can be equal or more effective than the regimen of opioid prescriptions used after TKA. To the best of our knowledge, there have been no studies conducted that directly examine the effect of prolonged multimodal pain regimen after hospital discharge in primary TKA patients. PURPOSE: 1. To determine whether a prolonged multimodal pain regimen after discharge from primary TKA can provide equivalent or better pain control while reducing opioid consumption and, subsequently, opioid-related side effects. 2. To determine whether patient expectations and routine opioid prescription practices at the time of discharge from primary TKA impacts opioid consumption.
Primary Outcome
Measured via Visual Analog scale (0-100mm)
Interventions
- DRUG Tylenol
- DRUG Oxycodone
- DRUG Gabapentin
- DRUG Tramadol
- DRUG Meloxicam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2017-12-21 |
| Est. Completion | 2019-03-15 |
| Phase | NA |
What the finished NCT04003350 record still lists
NCT04003350 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 5 interventions - of which Tylenol is the first listed.
NCT04003350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04003350 about?
NCT04003350 is a clinical study titled "The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty". It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. This multimodal analgesic regimen also leads to red...
What is the current status of trial NCT04003350?
This trial is currently completed. It is a NA study. The enrollment target is 216 participants. The study started on 2017-12-21. Estimated completion is 2019-03-15.
What interventions are being tested in trial NCT04003350?
The interventions under investigation include: Tylenol (DRUG), Oxycodone (DRUG), Gabapentin (DRUG), Tramadol (DRUG), Meloxicam (DRUG).
Who is sponsoring clinical trial NCT04003350?
This trial is sponsored by Rothman Institute Orthopaedics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04003350's enrollment target sits among peer trials
216 485th of 2000 higher than 1,514 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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