NAC-REPAIR for Post-surgical Pain

NCT07227649 — Phase 2, Not yet recruiting, 80 participants, University of Arizona

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NAC-REPAIR: N-Acetylcysteine-facilitated Redox-Immune Modulation for Post-surgical Analgesia and Injury Recovery

Registry	NCT07227649
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	80 (Estimated)
Sponsor	University of Arizona (Other); collaborators: Banner University Medical Center
Conditions	Carpal Tunnel Surgery, Trigger Finger Disorder, De Quervain Syndrome, Guyon's Canal, Dupuytren Contracture, Morton Neuroma, Tarsal Tunnel Syndrome, Plantar Fasciopathy, Peroneal Nerve Entrapment
Interventions	NAC, NAC 0mg/day (Placebo) (Drug)
Dates	start 2026-10-15 (estimated), primary completion 2027-01-15 (estimated), completion 2027-07-15 (estimated), first posted 2025-11-13, last updated 2026-07-17
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
N-Acetylcysteine (NAC)	Experimental	Drug: NAC	Intervention: Oral N-acetylcysteine capsules, 600 mg twice daily. Timing/Duration: Begin the evening before surgery (≤24 h pre-op) and continue through Post-op Day 14 (total 15 days; bottle overfilled to cover missed doses). Administration: Self-administered at home; counseling at baseline dispense; pill diary + pill counts. Concomitant care: All peri-operative care per standard of care (SoC), including multimodal analgesia; no high-dose antioxidant supplements; nitrates excluded. Objective: Test whether peri-operative NAC improves early pain, function, and recovery via redox-immune modulation.
Placebo	Placebo comparator	Drug: NAC 0mg/day (Placebo)	Intervention: Matched inert capsules (e.g., microcrystalline cellulose), identical in size/appearance/labeling to NAC. Timing/Duration: 600 mg-equivalent capsule count, twice daily, evening before surgery through Post-op Day 14. Administration: Same counseling, diary, and adherence checks as NAC arm. Concomitant care: Identical SoC allowances/restrictions as NAC arm.

NAC (Drug): Intervention: Oral N-acetylcysteine capsules, 600 mg twice daily. Timing/Duration: Begin the evening before surgery (≤24 h pre-op) and continue through Post-op Day 14 (total 15 days; bottle overfilled to cover missed doses). Administration: Self-administered at home; counseling at baseline dispense; pill diary + pill counts. Concomitant care: All peri-operative care per standard of care (SoC), including multimodal analgesia; no high-dose antioxidant supplements; nitrates excluded. Objective: Test whether peri-operative NAC improves early pain, function, and recovery via redox-immune modulation.
NAC 0mg/day (Placebo) (Drug): Intervention: Matched inert capsules (e.g., microcrystalline cellulose), identical in size/appearance/labeling to NAC. Timing/Duration: 600 mg-equivalent capsule count, twice daily, evening before surgery through Post-op Day 14. Administration: Same counseling, diary, and adherence checks as NAC arm. Concomitant care: Identical SoC allowances/restrictions as NAC arm. Randomization/Blinding: 1:1, stratified by surgery type (upper- vs lower-extremity); double-blind (participants, investigators, assessors). Primary comparisons: Early postoperative pain and function (e.g., PROMIS-PI/PF, QuickDASH or LEFS), opioid consumption; safety/tolerability.

+Outcome measures

Primary outcomes

PROMIS pain interference [baseline; post-op (2-4 weeks); post-op (12 weeks);]: Patient-Reported Outcomes Measurement Information System - Pain Interference T-score metric: mean = 50, SD = 10 Higher scores = worse outcome (greater pain interference with daily activities, social, cognitive, emotional, and physical functioning)

Secondary outcomes

PROMIS Physical Function [Baseline; post-op (2-4 weeks); post-op (12 weeks)]: Patient-Reported Outcomes Measurement Information System Physical Function T-score metric: mean = 50, SD = 10 Higher scores = better outcome (greater ability to carry out physical activities such as mobility, self-care, and instrumental activities)
Numeric Pain Rating Scale [Baseline; post-op (2-4 weeks); post-op (12 weeks)]: 0-10: 0 = no pain, 10 = worst imaginable Higher scores = worse outcome (greater perceived pain intensity)

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* 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
* Willing to follow dosing schedule and avoid restricted supplements/meds

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Banner Health	Tucson, Arizona	United States