Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
Recruiting · NCT06083480 · Interventional (participants receive a specific treatment) · Lead sponsor: Vanderbilt University Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
GlyNAC (combination of glycine and n-acetylcysteine)Placebo
What this trial is about
This is a prospective randomized controlled trial that will assess preoperative, perioperative, and long-term oxidative stress (OS); pain; and functional outcomes over a 12 month period and test the hypothesis that a potent antioxidant intervention (glycine + N-acetyl-cysteine(GlyNAC)) reduces oxidative stress and chronic post surgical pain (CPSP) in patients undergoing total knee arthroplasty (TKA).
Who can take part
Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age 50 or older
- Intact cognitive status and ability to provide informed consent (based on cognitive screening with the Mini Mental State Examination)
- Ability to read and write in English sufficiently to understand and complete study questionnaires
- Undergoing unilateral primary TKA
- Medical diagnosis of osteoarthritis
- Past 24 hour worst numeric rating scale (NRS) pain of at least 4/10.
Exclusion criteria
- Diagnosis of pre-existing neuropathy
- Untreated hypo/hyperthyroidism
- Untreated heart disease
- Alanine transaminase/aspartate transaminase \>2x upper-limit of normal range
- serum creatinine \>1.5 mg/dl
- Pregnancy
- Complex Regional Pain Syndrome (CRPS) diagnosis prior to undergoing TKA
- Presence of lower extremity vascular disease, inflammatory or autoimmune disorders, or malignancy
- Presence of current clinically significant chronic pain conditions outside of the lower extremity ( daily pain for \>3 months and greater ≥3/10 in intensity or the focus of medical care)
- Presence of other medical conditions that in the opinion of the orthopedic surgeon co-investigators would make a patient's study participation unsafe
Where it is running
1 location listed across 1 US state.
- Vanderbilt University Medical Center - Nashville, Tennessee, United States