Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
Vanderbilt University Medical Center
148 participants
Dec 6, 2024
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria6
- 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 Criteria10
- 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
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Interventions
GlyNAC 200 mg/kg/day (100mg glycine and 100mg N-acetyl-cysteine) will be administered orally in two divided doses each day for four weeks prior to TKA and six weeks postoperatively. The preparation will be a commercially available product of 1:1 ratio of glycine and N-acetyl-cysteine.
Placebo (alanine) 200 mg/kg/day will be administered orally in two divided doses each day for four weeks prior to TKA and six weeks postoperatively.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06083480