Status:
UNKNOWN
Improving Pain Management and Decreasing LOS After Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA)
Lead Sponsor:
More Foundation
Conditions:
Pain
Eligibility:
All Genders
50-80 years
Phase:
PHASE4
Brief Summary
This two arm, patient blinded, randomized, post market clinical trial in a single orthopedic hospital will determine whether there is improved pain management and decreased length of stay when compari...
Detailed Description
This two arm, patient blinded, randomized, post market clinical trial in a single orthopedic hospital will determine whether there is improved pain management and decreased length of stay (LOS) when c...
Eligibility Criteria
Inclusion
- Adults 50 to 80 years, inclusive
- Planned primary THA or TKA
- Expressed willingness to be discharged the same day of surgery if condition allows
- American Society of Anesthesiologists (ASA) physical classes I - III
- ASA I: A normal healthy patient. Example: Fit, nonobese (BMI under 30), a nonsmoking patient with good exercise tolerance.
- ASA II: A patient with a mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (e.g., treated hypertension, obesity with BMI under 35, frequent social drinker or is a cigarette smoker).
- ASA III: A patient with a severe systemic disease that is not life-threatening. Example: Patient with some functional limitation as a result of disease (e.g., poorly treated hypertension or diabetes, morbid obesity, chronic renal failure, a bronchospastic disease with intermittent exacerbation, stable angina, implanted pacemaker).
- Patients who are English competent.
Exclusion
- Opioid tolerant (\> 50 mg oral morphine milligram equivalents (MMEs) daily)
- Current IV drug abuse
- History of alcoholism
- History of severe renal impairment
- History of severe hepatic impairment
- Dependent on supplemental oxygen at home
- Pregnant
- Incarcerated
- Patient unable to provide informed consent
- Patients undergoing bilateral TKA, THA
- Patient undergoing unicompartmental knee arthroplasty (UKA)
- Patients undergoing other concurrent surgery
- Patients with a history of allergy to any drugs in the study.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05307341
Start Date
March 1 2022
End Date
June 1 2023
Last Update
April 1 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The CORE Institute Specialty Hospital
Phoenix, Arizona, United States, 85015