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NCT Number: NCT07227649

NAC-REPAIR for Post-surgical Pain

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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Key information

Conditions

Carpal Tunnel Surgery Connective Tissue Diseases Contracture De Quervain Syndrome Dupuytren Contracture Fibroma Foot Diseases Guyon's Canal Joint Diseases Metatarsalgia Mononeuropathies Morton Neuroma Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Nerve Compression Syndromes Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Peroneal Nerve Entrapment Peroneal Neuropathies Plantar Fasciopathy Signs and Symptoms Skin and Connective Tissue Diseases Tarsal Tunnel Syndrome Tendinopathy Tendon Entrapment Tibial Neuropathy Trigger Finger Disorder

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. PROMIS pain interference

    Time frame: 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

  1. PROMIS Physical Function

    Time frame: 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)

  2. Numeric Pain Rating Scale

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Valerio Tonelli Enrico, PT, PhD, MSCE

CONTACT

[email protected]

17068097067

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • Banner University Medical Center

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 13, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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