GlyNAC to Reduce Pain After Total Knee Replacement

This study is looking at whether a combination of glycine and N-acetylcysteine, called GlyNAC, can help reduce chronic pain after total knee replacement surgery. Many people have this surgery for osteoarthritis, but some still experience long-term pain. Researchers believe that reducing "oxidative stress" (a type of imbalance in the body) around the time of surgery might help. You would receive either GlyNAC or a placebo (an inactive substance called alanine) for four weeks before surgery and six weeks after. The main goal is to see if GlyNAC can lower your worst pain rating up to 6 months after surgery. To join, you must be 50 or older, have osteoarthritis, be having a total knee replacement, and be able to read and write in English.

Study design
This is a randomized controlled trial, meaning you would be randomly assigned to receive either GlyNAC or a placebo. The study plans to enroll 148 participants.
What's involved
You would take the study medication (GlyNAC or placebo) orally twice daily for four weeks before your surgery and six weeks afterward.
Compensation
Not stated in the trial record.
Follow-up
Your pain levels will be monitored from before surgery up to 6 months after your total knee replacement.

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NCT06083480

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

Recruiting
PHASE4Ages 50+InterventionalPrevention
Vanderbilt University Medical Center
~148 participants
Updated 2025-12-11 on ClinicalTrials.gov
What's tested:GlyNAC (combination of glycine and n-acetylcysteine)Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Numeric Rating Scale (NRS) Rating of Worst Pain in the past 24 hours
Measured over Baseline to 6 months post TKA (approximately 7 months)
Osteoarthritis, Knee
Total Knee Arthroplasty
Chronic Postsurgical Pain
1 sites across 1 states
Tennessee1
  • Stephen Bruehl, Ph.D. · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center
  • Frederic T Billings, IV, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Numeric Rating Scale (NRS) Rating of Worst Pain in the past 24 hoursBaseline to 6 months post TKA (approximately 7 months)

    Mean within participant changes in NRS intensity ratings of worst pain in past 24 hours of measurement at 6 months post TKA. The score is a rating of current acute pain using a 0-100 numeric rating scale (NRS) (0 = "no pain" and 100 = "worst possible pain").