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Dexamethasone for Knee Surgery

Phase 4
Recruiting
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18 years
Patients staying at least one night in the hospital after surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48-hours postoperative (after surgical intervention)
Awards & highlights

Study Summary

This trial is testing whether a lower dose of the steroid dexamethasone given during surgery can reduce postoperative pain and the need for opioids without increasing other complications.

Who is the study for?
This trial is for adults over 18 who are staying in the hospital at least one night after a primary total knee replacement surgery. It's not for those with inflammatory arthritis, current fungal infections, kidney or liver failure, planned same-day discharge, recent corticosteroid use, or a history of bad reactions to steroids.Check my eligibility
What is being tested?
The study is testing three different doses of dexamethasone (16mg, 8mg/mL suspension, and 4mg) given during knee replacement surgery. The goal is to see which dose best reduces pain and opioid need after surgery while also lowering nausea/vomiting and complications.See study design
What are the potential side effects?
Dexamethasone may cause side effects like increased blood sugar levels, higher risk of infection due to immune suppression, mood swings or sleep disturbances. Long-term use can lead to bone loss or stomach ulcers but this trial involves a single dose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I stayed in the hospital overnight after my surgery.
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I am having or have had a total knee replacement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~<30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and <30 days after surgical intervention, document any readmissions to the hospital or complications that occur within 30 days from the day of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Opioid consumption
Secondary outcome measures
Length of stay
Number of participants with complications (such as readmission to hospital) up to 30 days after surgical intervention
Postoperative Blood glucose levels and insulin use
+3 more

Trial Design

3Treatment groups
Active Control
Group I: Group 1Active Control1 Intervention
4mg intravenous dexamethasone, administered shortly after induction of anesthesia
Group II: Group 2Active Control1 Intervention
8mg intravenous dexamethasone, administered shortly after induction of anesthesia
Group III: Group 3Active Control1 Intervention
16mg intravenous dexamethasone, administered shortly after induction of anesthesia

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
163,072 Total Patients Enrolled

Media Library

Group 1 Clinical Trial Eligibility Overview. Trial Name: NCT05018091 — Phase 4
Total Knee Replacement Research Study Groups: Group 1, Group 2, Group 3
Total Knee Replacement Clinical Trial 2023: Group 1 Highlights & Side Effects. Trial Name: NCT05018091 — Phase 4
Group 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT05018091 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any related experiments that have been conducted within Group 1?

"The Manitoba Blood & Marrow Transplant Program CancerCare Manitoba conducted the first Group 1 research in 2002. Since then, 1098 trials have concluded and 553 are still running actively - notably many of them hosted at Rochester, Minnesota."

Answered by AI

How many individuals are participating in this exploration?

"For this medical investigation to be successful, 429 individuals who meet the established criteria must take part. Among other places, Mayo Clinic Institutional Review in Rochester, Minnesota and Columbia University Irving Medical Center in New york will act as sites for enrolment."

Answered by AI

In what scenarios is Group 1 typically administered?

"Group 1 is recommended for the treatment of ophthalmia, sympathetic eye disorder, and branch retinal vein occlusion."

Answered by AI

Has Group 1 acquired the necessary authorization from the FDA?

"In our assessment, Group 1 earned a 3 for safety due to the successful completion of Phase 4 trials and ultimate approval by regulatory bodies."

Answered by AI

Are there any vacancies to join this investigation?

"Yes, the records available on clinicaltrials.gov affirm that this trial is currently recruiting individuals to participate. Initially posted on October 28th 2021 and most recently updated just a few weeks ago, 429 patients are needed from 8 different sites."

Answered by AI

Are there extensive sites in North America that are carrying out this research?

"The Mayo Clinic Institutional Review Board in Rochester, Minnesota, the Columbia University Irving Medical Center of New york City and Shiley Center for Orthopaedic Research and Education at Scripps Clinic in La Jolla, California are a few of the sites recruiting participants. Additionally, there is another 8 trial locations."

Answered by AI

Who else is applying?

What site did they apply to?
Rush University medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Other pain drugs haven't helped.
PatientReceived no prior treatments
Recent research and studies
~0 spots leftby May 2024