Clinical trial · Interventional
NAC-REPAIR for Post-surgical Pain
NAC-REPAIR: N-Acetylcysteine-facilitated Redox-Immune Modulation for Post-surgical Analgesia and Injury Recovery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carpal Tunnel Surgery | — | UNRESOLVED | — |
| De Quervain Syndrome | — | UNRESOLVED | — |
| Dupuytren Contracture | Palmar Fibromatosis | ALIAS | 0.90 |
| Guyon's Canal | — | UNRESOLVED | — |
| Morton Neuroma | — | UNRESOLVED | — |
| Peroneal Nerve Entrapment | — | UNRESOLVED | — |
| Plantar Fasciopathy | — | UNRESOLVED | — |
| Tarsal Tunnel Syndrome | — | UNRESOLVED | — |
| Trigger Finger Disorder | — | UNRESOLVED |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NAC | Drug | — | UNRESOLVED |
| NAC 0mg/day (Placebo) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- N-Acetylcysteine (NAC)
- description
- 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.
- interventionNames
- Drug: NAC
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available