Phase 2
Completed N=50
A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.
Surgery
Source: ClinicalTrials.gov NCT04562597 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcomePrimary: Opioid Consumption 12 Hours Post Operative — 19.4; 15.6 IV morphine mg equivalents
Summary
Determine the optimal dose of IV N-acetylcysteine (NAC) to produce opioid reduction following spine surgery and estimate the difference in opioid consumption between placebo and the selected optimal dose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Consumption 12 Hours Post Operative |
19.4; 15.6 | — |
| SECONDARY Opioid Consumption Every 6 Hours Post Operative |
14.6; 12.0; 25.0; 19.9; 29.6; 24.7 | — |
Eligibility Criteria
Inclusion Criteria
- Undergoing elective spine surgery involving 4 levels or less of the thoracic, lumbar, or sacral spine.
- 18 years of age and older.
Exclusion Criteria
- Less than 40kg in weight.
- Unable to provide written, informed consent.
- History of an adverse or anaphylactoid reaction to acetylcysteine.
- Active asthma, wheezing, or using inhaled bronchodilators.
- Pregnant Women
- Known blood clotting deficiency
Data sourced from ClinicalTrials.gov (NCT04562597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.