NAC-REPAIR for Post-surgical Pain

Not Applicable

Not yet recruiting

• 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: Drug: NAC; Drug: NAC 0mg/day (Placebo)

• Registration Number: NCT07227649
• Lead Sponsor: University of Arizona

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-10
• Study First Submitted QC: 2025-11-10
• Last Update Submitted: 2025-11-12
• Study First Posted: 2025-11-13
• Last Update Posted: 2025-11-14
• Study Start: 2026-01-15
• Primary Completion: 2027-01-15
• Study Completion: 2027-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-Acetylcysteine (NAC)	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	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Banner Health; 🇺🇸 Tucson, Arizona, United States