Phase 2
N=24
Oxidative Stress and Surgical Recovery
Surgical Recovery · Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT04732000 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Phosphorylation of STAT-3 in MDSC (Myeloid-derived Suppressor Cells) — 2.162; 2.025 STAT3 archsinh ratio — p=0.5490
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-acetyl cysteine (Drug); Normal Saline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phosphorylation of STAT-3 in MDSC (Myeloid-derived Suppressor Cells) |
2.162; 2.025 | 0.5490 |
| PRIMARY Brief Pain Inventory Pain Score |
1.3; 1.0; 2.5; 1.0 | — |
| SECONDARY Pain Score |
5.5; 4.5; 4.3; 4.0; 7.0; 5.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Over 18
- Male of female
- Planning to undergo primary total hip arthroplasty
- Fluent in English
- Willing and able to sign an informed consent form and HIPAA authorization and to comply with study procedures
Exclusion Criteria
- Infectious disease within the last month
- Immune-suppressant therapy within the last 2 months (e.g., azathioprine or cyclosporine)
- Chronic medication with potential immune-modulatory effects (e.g., daily oral morphine-equivalent intake > 30 mg)
- Major surgery within the last 3 months or minor surgery within the last month.
- History of substance abuse (e.g., alcoholism, drug dependency)
- Pregnancy
- Autoimmune disease interfering with data interpretation (e.g. lupus)
- Renal, hepatic, cardiovascular, or respiratory diseases resulting in clinically relevant impaired function
- Active malignancy
- 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
- Other conditions compromising a participant's safety or the integrity of the study
Data sourced from ClinicalTrials.gov (NCT04732000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.