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| Name | Class |
|---|---|
| Banner University Medical Center | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-Acetylcysteine (NAC) | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS pain interference | 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) | baseline; post-op (2-4 weeks); post-op (12 weeks); |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Physical Function | 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) | Baseline; post-op (2-4 weeks); post-op (12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valerio Tonelli Enrico, PT, PhD, MSCE | Contact | 17068097067 | vte@arizona.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Health | Tucson | Arizona | 85721 | United States |
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| ID | Term |
|---|---|
| D052582 | Trigger Finger Disorder |
| D004387 | Dupuytren Contracture |
| D000070607 | Morton Neuroma |
| D013641 | Tarsal Tunnel Syndrome |
| D020427 | Peroneal Neuropathies |
| ID | Term |
|---|---|
| D053682 | Tendon Entrapment |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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. |
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| Numeric Pain Rating Scale |
0-10: 0 = no pain, 10 = worst imaginable Higher scores = worse outcome (greater perceived pain intensity) |
| Baseline; post-op (2-4 weeks); post-op (12 weeks) |
| D005350 |
| Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003286 | Contracture |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D037061 | Metatarsalgia |
| D005534 | Foot Diseases |
| D007592 | Joint Diseases |
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020429 | Tibial Neuropathy |
| D020422 | Mononeuropathies |
| D009408 | Nerve Compression Syndromes |