Oxidative Stress and Surgical Recovery

• Status: Enrolling by invitation
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic pain, functional impairment and slow rates of recovery are key issues for patients after surgery and trauma. No preventative strategy in current use unequivocally modifies these rates, and few novel approaches have been tested. Furthermore, persistent postsurgical pain is a major route to chronic opioid use, opioid use disorder and, regrettably, opioid overdose. Most strategies designed to limit chronic pain or enhance functional recovery after surgery are directed at modulating peripheral and central nervous system activity and do not strongly modify the underlying tissue pathophysiology or fundamental systemic responses. Strategies limiting oxidative stress in the perioperative period, on the other hand, might limit tissue damage, organ dysfunction and immune system activation.

N-acetyl cysteine (NAC) is an antioxidant well-studied in the perioperative period; it is very safe, relatively inexpensive and widely available. The central hypothesis is, therefore, that perioperative administration of NAC will reduce perioperative oxidative stress, limit immune system activation and improve key indices of surgical recovery. Although the planned work will not comprehensively address this hypothesis, it will identify the most useful tools and help the researchers estimate the required sample sizes for more definitive externally funded efforts.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

1. Over 18

2. Male of female

3. Planning to undergo primary total hip arthroplasty

4. Fluent in English

5. Willing and able to sign an informed consent form and HIPAA authorization and to comply with study procedures

Exclusion Criteria:

1. Infectious disease within the last month

2. Immune-suppressant therapy within the last 2 months (e.g., azathioprine or cyclosporine)

3. Chronic medication with potential immune-modulatory effects (e.g., daily oral morphine-equivalent intake > 30 mg)

4. Major surgery within the last 3 months or minor surgery within the last month.

5. History of substance abuse (e.g., alcoholism, drug dependency)

6. Pregnancy

7. Autoimmune disease interfering with data interpretation (e.g. lupus)

8. Renal, hepatic, cardiovascular, or respiratory diseases resulting in clinically relevant impaired function

9. Active malignancy

10. Participation in another clinical trial of an investigational drug or device within the last month that, in the investigator's opinion, would create an increased risk to the participant or compromise the integrity of the study

11. Other conditions compromising a participant's safety or the integrity of the study