RecruitingPhase 4NCT06083480

Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty


Sponsor

Vanderbilt University Medical Center

Enrollment

148 participants

Start Date

Dec 6, 2024

Study Type

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

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called GlyNAC (combination of glycine and n-acetylcysteine) and a drug called Placebo for people with chronic postsurgical pain, osteoarthritis, knee, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 50 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlyNAC (combination of glycine and n-acetylcysteine)

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.

DRUGPlacebo

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)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT06083480


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