Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• 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.
Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Stephen Bruehl, Ph.D.
stephen.bruehl@vumc.org
(615) 936-1821
Backup
Gail Mayo, RN
gail.mayo@vumc.org
615-936-1705
Time Frame
Start Date:2024-12-06
Estimated Completion Date:2029-03
Participants
Target number of participants:148
Treatments
Experimental: GlyNAC (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.
Placebo_comparator: Placebo (alanine)
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.