A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of South Carolina
• Treatments: Acetylcysteine; N-monoacetylcystine

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