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

Description

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).

Conditions

Osteoarthritis, Knee, Total Knee Arthroplasty, Chronic Postsurgical Pain

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Osteoarthritis, Knee
Intervention / Treatment

-

Contacts and Locations

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt University Medical Center,

Stephen Bruehl, Ph.D., PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Frederic T Billings, IV, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

2029-03