Carpal Tunnel Surgery, Trigger Finger Disorder, De Quervain Syndrome, Guyon's Canal, Dupuytren Contracture, Morton Neuroma, Tarsal Tunnel Syndrome, Plantar Fasciopathy, Peroneal Nerve Entrapment
Conditions
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.
Interventions
DRUGNAC
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.
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.
Sponsors
Banner University Medical Center
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Contacts
Primary ContactValerio Tonelli Enrico, PT, PhD, MSCE
Outcome results
None listed