Carpal Tunnel SurgeryPhase 2NCT07227649
NAC-REPAIR for Post-surgical Pain
A Phase 2 study testing NAC in people with Carpal Tunnel Surgery and Trigger Finger Disorder, run by University of Arizona at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carpal Tunnel Surgery, Trigger Finger Disorder, De Quervain Syndrome
- What is being tested?
- NAC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 15 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Banner Health
Tucson, Arizona, 85721
Valerio Tonelli Enrico, 7068097067, vte@arizona.edu
About this study
Official title: NAC-REPAIR: N-Acetylcysteine-facilitated Redox-Immune Modulation for Post-surgical Analgesia and Injury Recovery
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
- Carpal Tunnel Surgery, Trigger Finger Disorder, De Quervain Syndrome, Guyon's Canal, Dupuytren Contracture, Morton Neuroma
- Being tested
- NAC, NAC 0mg/day (Placebo)
- Medical subject headings
- Trigger Finger Disorder, Dupuytren Contracture, Morton Neuroma, Tarsal Tunnel Syndrome, Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NACDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: NAC |
| 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. Receives: Drug: NAC 0mg/day (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline; post-op (2-4 weeks); post-op (12 weeks);
Secondary outcomes (2)
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)
Measured: Baseline; post-op (2-4 weeks); post-op (12 weeks)
Numeric Pain Rating Scale
0-10: 0 = no pain, 10 = worst imaginable Higher scores = worse outcome (greater perceived pain intensity)
Measured: Baseline; post-op (2-4 weeks); post-op (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start15 Oct 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Banner University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227649
- Sponsor's protocol ID
- STUDY00007009
- Status last verified
- Nov 2025
- First submitted
- 10 Nov 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAC-REPAIR: N-Acetylcysteine-facilitated Redox-Immune Modulation for Post-surgical Analgesia and Injury Recovery
- ClinicalTrials.gov ID
- NCT07227649
- Acronym / sponsor ID
- STUDY00007009
- Conditions
- Carpal Tunnel Surgery, Trigger Finger Disorder, De Quervain Syndrome, Guyon's Canal, Dupuytren Contracture, Morton Neuroma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Banner University Medical Center
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 13 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N-Acetylcysteine (NAC) | Experimental | Drug: NACIntervention: 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. |
| Placebo | Placebo comparator | 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NACIntervention: 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. | Drug | N-Acetylcysteine (NAC) |
| 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, assessors). Primary comparisons: Early postoperative pain and function (e.g., PROMIS-PI/PF, QuickDASH or LEFS), opioid consumption; safety/tolerability. | Drug | Placebo |
Primary outcome
PROMIS pain interference
Time frame: 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)
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NAC in people with Carpal Tunnel Surgery and Trigger Finger Disorder, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valerio Tonelli Enrico, PT, PhD, MSCE (17068097067, vte@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS pain interference (time frame: baseline; post-op (2-4 weeks); post-op (12 weeks);). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.