NAC-REPAIR for Post-surgical Pain

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT07227649
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Carpal Tunnel Surgery
  • De Quervain Syndrome
  • Dupuytren Contracture
  • Guyon's Canal
  • Morton Neuroma
  • Peroneal Nerve Entrapment
  • Plantar Fasciopathy
  • Tarsal Tunnel Syndrome
  • Trigger Finger Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Nov 2025
Primary completion
Jan 15, 2027
Completion
Jul 15, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: N-Acetylcysteine (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 Comparator: 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 Measure

PROMIS pain interference [ Time Frame: baseline; post-op (2-4 weeks); post-op (12 weeks); ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Banner HealthTucsonArizona85721
Valerio Tonelli Enrico
[email protected]
7068097067

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By research site
Banner Health· Tucson, AZ

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