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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 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 45 participants.
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.
Interventions
- OTHER Placebo
- DRUG Dexamethasone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-12 |
| Est. Completion | 2016-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02271698
The ClinicalTrials.gov registry entry for NCT02271698 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02271698 reports 0 study locations.
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.
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