NAC-REPAIR: N-Acetylcysteine-facilitated Redox-Immune Modulation for Post-surgical Analgesia and Injury Recovery
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- PROMIS pain interference
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: NAC (Drug)
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.
干预措施: NAC 0mg/day (Placebo) (Drug)
结局指标
主要结局
PROMIS pain interference
时间窗: 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)
PROMIS pain interference
时间窗: 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)
次要结局
- PROMIS Physical Function(Baseline; post-op (2-4 weeks); post-op (12 weeks))
- Numeric Pain Rating Scale(Baseline; post-op (2-4 weeks); post-op (12 weeks))
- PROMIS Physical Function(Baseline; post-op (2-4 weeks); post-op (12 weeks))
- Numeric Pain Rating Scale(Baseline; post-op (2-4 weeks); post-op (12 weeks))