About this trial
This pilot asks whether peri-operative N-acetylcysteine (NAC) improves recovery after common outpatient hand/foot-ankle surgery-specifically, does NAC reduce pain and opioid use and enhance function by modulating redox-inflammatory pathways? Primary objectives are to establish feasibility (accrual, adherence, follow-up), estimate NAC vs placebo effects on pain, function, and opioid consumption, and characterize inflammatory signatures that may predict response.
Methods: a single-site, double-blind, 1:1 randomized trial (N≈80) comparing NAC 1,200 mg twice daily for 14 days (starting pre-op) vs matching placebo; daily e-diaries for POD0-14; standardized outcomes (PROMIS Pain Interference; QuickDASH or FAAM; PGIC; opioid MME); and small blood draws pre-surgery and at two follow-up visits for cytokine profiling.
Eligibility criteria
Qualifiers
Elective outpatient hand/upper-extremity or foot/ankle surgery (single site; same-day discharge)
Baseline visit feasible ≤14 days pre-op
Can complete surveys/blood draw
Provides informed consent
Disqualifiers
Allergy to NAC/capsule components □ NAC or high-dose antioxidants in past 14 days (unwilling to stop)
Chronic daily opioids ≥3 months or OUD/maintenance therapy □ Pregnant/breastfeeding or no contraception as applicable
Daily nitrates (nitroglycerin/isosorbide) □ Planned >24h admission, multistage/trauma case □ Other interventional study within 30 days
Unable to swallow capsules / malabsorption surgery affecting oral meds
Trial design
Treatments tested in this trial
- NAC
- NAC 0mg/day (Placebo)
Treatment groups
Sponsors and collaborators
University of Arizona
Lead sponsor
Banner University Medical Center
Collaborator