Reducing Perioperative Oxidative Stress to Prevent Postoperative Chronic Pain Following Total Knee Arthroplasty
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorVanderbilt University Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Diagnosis of pre-existing neuropathy
Untreated hypo/hyperthyroidism
Untreated heart disease
Alanine transaminase/aspartate transaminase >2x upper-limit of normal range
Trial design
Design model
Parallel
Treatments tested in this trial
GlyNAC (combination of glycine and n-acetylcysteine)
DrugGlyNAC 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
DrugPlacebo (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.
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: GlyNAC (combination of glycine and n-acetylcysteine)Experimental treatment 1 intervention
Group B: Placebo (alanine)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Numeric Rating Scale (NRS) Rating of Worst Pain in the past 24 hours
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").
Time frame
Baseline to 6 months post TKA (approximately 7 months)Secondary outcomes
1
Numeric Rating Scale (NRS) Rating of Worst Pain in the past 24 hours
Mean within participant changes in NRS intensity ratings of worst pain in past 24 hours of measurement. 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")
Time frame
Baseline to 6 weeks and 12 months post TKA (13 months)2
Numeric Rating Scale of Average Pain in the past 24 hours
Mean within participant changes in NRS intensity ratings of average pain in past 24 hours of measurement. 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").
Time frame
Baseline to 6 weeks, 6 months and 12 months post TKA (13 months)3
Numeric Rating Scale of Least Pain in the past 24 hours
Mean within participant changes in NRS intensity ratings of least pain in past 24 hours of measurement. 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").
Time frame
Baseline to 6 weeks, 6 months and 12 months post TKA (13 months)4
Mean change in McGill Pain Questionnaire-2 (MPQ-2) ratings of knee pain for average pain over past week of measurement.
Mean within participant changes in McGill Pain Questionnaire-2 (MPQ-2) ratings of knee pain for average pain over past week of measurement. The MPQ-2 score ranges from 0-10 where 0 represents no pain and 10 represents the most intense pain.
Time frame
Baseline to 6 weeks, 6 months and 12 months post TKA (13 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanderbilt University Medical Center
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov