Reducing oxidative stress to prevent chronic pain after knee surgery
Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
This study is testing if a special antioxidant can help people who have knee surgery feel less pain and recover better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT06083480 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective randomized controlled trial aimed at evaluating the effects of a potent antioxidant intervention, GlyNAC, on oxidative stress and chronic postsurgical pain in patients undergoing total knee arthroplasty (TKA). The study will assess preoperative, perioperative, and long-term outcomes over a 12-month period, focusing on pain levels and functional improvements. By targeting oxidative stress, the trial seeks to determine if reducing this biological factor can lead to better pain management and recovery for TKA patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 or older who are scheduled for unilateral primary total knee arthroplasty due to osteoarthritis.
Not a fit: Patients with pre-existing neuropathy, untreated thyroid or heart conditions, or significant chronic pain conditions outside of the lower extremity may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of chronic pain following total knee arthroplasty, improving quality of life for many patients.
How similar studies have performed: While the approach of using antioxidants to mitigate postoperative pain is promising, this specific intervention has not been extensively tested in prior studies, making it a novel exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Bruehl, Ph.D. — Vanderbilt University Medical Center
- Study coordinator: Stephen Bruehl, Ph.D.
- Email: stephen.bruehl@vumc.org
- Phone: (615) 936-1821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.