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Not yet recruiting NCT07227649

NAC-REPAIR for Post-surgical Pain

Phase II Interventional Carpal Tunnel Surgery Trigger Finger Disorder De Quervain Syndrome Guyon's Canal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NAC, NAC 0mg/day (Placebo).
Who it may be relevant to
Registry conditions: Carpal Tunnel Surgery, Trigger Finger Disorder, De Quervain Syndrome, Guyon's Canal. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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:
  • 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. Randomization/Blinding: 1:1, stratified by surgery type (upper- vs lower-extremity); double-blind (participants, investigators

Primary outcome measures

  • PROMIS pain interference [Time frame: baseline; post-op (2-4 weeks); post-op (12 weeks);]
Secondary outcome measures (2)
  • PROMIS Physical Function [Time frame: Baseline; post-op (2-4 weeks); post-op (12 weeks)]
  • Numeric Pain Rating Scale [Time frame: Baseline; post-op (2-4 weeks); post-op (12 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Banner Health — Tucson

Identifiers

NCT: NCT07227649 · STUDY00007009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗