Status:
COMPLETED
Influence of Patient Sex on Pain Control and Multimodal Analgesia in Total Knee Arthroplasty
Lead Sponsor:
Northwell Health
Conditions:
Knee Osteoarthritis
Pain, Postoperative
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the influence of sex on postoperative pain, following total knee arthroplasty (TKA). Patients will first be stratified by sex and then be randomized into one of...
Detailed Description
The overall goal of this study is to better understand the influence of patient-sex on postoperative pain perception in men versus women following total knee arthroplasty (TKA) utilizing two different...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, age 18-80
- Undergoing primary unilateral TKA for primary osteoarthritis
- English speaking
- Patients whose primary residence is in a home and not a facility or rehabilitation center.
Exclusion
- Chronic (\>6 months) use of neuromodulators pregabalin or gabapentin.
- Pregnancy or lactation
- Prior history of adverse reactions to pregabalin
- Coexisting chronic pain condition rated ≥50mm on 100-mm VAS requiring narcotics.
- Coexisting condition leading to sedation or dizziness
- Kidney disease
- History of angioedema
- History of depression with suicidal ideation.
- Extensive history of opioid/ substance use and/or abuse.
- Receiving active or maintenance treatment for cancer or solid organ and/or marrow transplant.
- Patient staying less than one night in the hospital.
- Patients with a history of chronic obstructive pulmonary disease (COPD) with supplementary oxygen requirements.
Key Trial Info
Start Date :
December 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04471233
Start Date
December 9 2020
End Date
June 20 2023
Last Update
October 1 2024
Active Locations (1)
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1
Northwell Health Orthopedic Institute at Great Neck
Great Neck, New York, United States, 11021