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NCT02271698 · ClinicalTrials.gov registry record · Phase 4
Dexamethasone and Pain Following Total Knee Arthroplasty
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 45
- Enrollment target
NCT02271698: Completed Phase 4 study, sponsored by Duke University.
NCT02271698 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 45 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02271698, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of the study is three fold. First to determine the ideal dose of dexamethasone intraoperatively that will reduce acute pain and opioid consumption. Second determine if dexamethasone at the time of surgery reduces chronic pain following total knee arthroplasty and finally determine if a pro-inflammatory environment makes patients susceptible to chronic pain after surgery and can dexamethasone alter this environment. Patients undergoing total knee arthroplasty will be randomized to four groups ( 0mg, 6mg, 12mg and 24mg dexamethasone) and assessments will be made of acute and chronic pain and quality of life measures. Blood samples will be drawn to assess Interleukin levels and for Macrophage sorting. For the primary efficacy endpoint of reduction of opioid consumption over 24 hours after surgery the dexamethasone regimen group will be compared to standard of care group using t-test. For comparisons of the secondary efficacy endpoints, t-test, Chi-square test and Fisher's Exact test will be used. Risks of this study include the risks of venipuncture and intravenous dexamethasone administration.
Primary Outcome
Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where "0" represents no pain and "10" represents worst pain ever.
Interventions
- OTHER Placebo
- DRUG Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-12 |
| Est. Completion | 2016-07 |
| Phase | Phase 4 |
What the finished NCT02271698 record still lists
NCT02271698 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02271698 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02271698 about?
NCT02271698 is a clinical study titled "Dexamethasone and Pain Following Total Knee Arthroplasty". The purpose of the study is three fold. First to determine the ideal dose of dexamethasone intraoperatively that will reduce acute pain and opioid consumption. Second determine if dexamethasone at the time of surgery reduces chronic pain following total knee arthroplasty and finally determine if a p...
What is the current status of trial NCT02271698?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 45 participants. The study started on 2014-12. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02271698?
The interventions under investigation include: Placebo (OTHER), Dexamethasone (DRUG).
Who is sponsoring clinical trial NCT02271698?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02271698's enrollment target sits among peer trials
45 1354th of 2000 higher than 638 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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