Status:
COMPLETED
Dexamethasone and Pain Following Total Knee Arthroplasty
Lead Sponsor:
Duke University
Conditions:
Acute Pain
Chronic Pain
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief 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...
Detailed Description
This is a Phase IV single center, prospective, randomized, double-blind, dose response study designed to evaluate the optimum dose of dexamethasone to administer as an analgesic in total knee arthropl...
Eligibility Criteria
Inclusion
- Patients scheduled to undergo unilateral total knee arthroplasty.
- American Society of Anesthesiology (ASA) Physical Class 1-3.
- BMI \<40 kg/m2
Exclusion
- Revision surgery.
- Bilateral total knee arthroplasty.
- Unicompartmental knee arthroplasty.
- Patients with a contraindication to regional anesthesia. This includes abnormal clotting, skin infection in groin or near the back, the presence of neurological disorders or anatomical abnormalities of the vertebral column.
- Contraindications or known drug interactions with dexamethasone.
- Use of any of the following medications within the times specified before surgery:
- Long-acting opioid medication within 3 days.
- Any opioid medication within 24 hours.
- Body weight less than 50 kilograms (\~110 pounds).
- Planned administration of another investigational product or procedure during the subject's participation in this study.
- Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postoperative course.
- Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function (Ejection fraction under 35%), epilepsy, myasthenia gravis), severe renal impairment (creatinine \> 1.8), comorbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT02271698
Start Date
December 1 2014
End Date
July 1 2016
Last Update
February 20 2018
Active Locations (1)
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1
DUMC
Durham, North Carolina, United States, 27710