NAC-REPAIR for Post-surgical Pain

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Arizona

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

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Arizona

Lead sponsor

Banner University Medical Center

Collaborator