Overview

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

Status:
Not yet recruiting
Trial end date:
2029-03-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vanderbilt University Medical Center
Collaborator:
National Institute on Aging (NIA)
Treatments:
Acetylcysteine
Glycine
N-monoacetylcystine
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