Opioid Reduction with Optimal N-acetylcysteine Dose for Surgery

Phase 1 & 2

Waitlist Available

Led By Sylvia Wilson, MD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-48 hours

Awards & highlights

Study Summary

This trial is designed to find the best dose of N-acetylcysteine to reduce the amount of opioids needed after spine surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid Consumption 12 Hours Post Operative

Secondary outcome measures

Opioid Consumption Every 6 Hours Post Operative

Trial Design

6Treatment groups

Active Control

Placebo Group

Group I: Dose Response Curve N-acetylcysteine 100 mg/kgActive Control1 Intervention

5 participants will be randomized to the N-acetylcysteine 100 mg/kg group to estimate the dose response curve and to identify the optimal dose.

Group II: Dose Response Curve N-acetylcysteine 150 mg/kgActive Control1 Intervention

5 participants will be randomized to the N-acetylcysteine 150 mg/kg group to estimate the dose response curve and to identify the optimal dose.

Group III: Opioid Reduction with Optimal N-acetylcysteine DoseActive Control1 Intervention

Once the optimal N-acetylcysteine dose is identified, 15 additional participants will be randomized to the optimal dose to estimate the difference in opioid consumption between patients on placebo vs. the optimal dose. Primary and secondary outcomes will only be evaluated for the placebo group and optimal NAC group.

Group IV: Dose Response Curve N-acetylcysteine 50 mg/kgActive Control1 Intervention

5 participants will be randomized to the N-acetylcysteine 50 mg/kg group to estimate the dose response curve and to identify the optimal dose.

Group V: PlaceboPlacebo Group1 Intervention

15 Participants will be randomized to placebo to estimate the difference in opioid consumption between patients on placebo vs. the optimal dose. Primary and secondary outcomes will only be evaluated for the placebo group and optimal NAC group.

Group VI: Dose Response Curve PlaceboPlacebo Group1 Intervention

5 participants will be randomized to the placebo group to estimate the dose response curve and to identify the optimal dose.

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