Recruiting

Phase 3

NAC vs. PlaceboNAC vs Placebo on Opioid Use for Hysterectomy

Sponsor:

Medical University of South Carolina

Code:

NCT06039566

Conditions

Hysterectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IV N-acetylcysteine

IV Placebo

Study Details

Brief summary:

This study will enroll females who are ages 18 and older undergoing a laparoscopic or robotic, partial or full hysterectomy. Participants will be randomized to receive IV n-acetylcysteine or placebo during the first 60 minutes of their procedure. At various time points after the procedure patients will be asked to report their pain scores, and any pain medication taken.

Conditions

Hysterectomy

Study ID

NCT06039566

Start date

Nov 30, 2023

Status verified date

Oct, 2025

Completion date

Dec 9, 2026

Anticipated

Primary completion date

Nov 25, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion

Undergoing elective laparoscopic or robotic, full, or partial hysterectomy procedure
18 years of age and older

Exclusion

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
Non-English speaking
Insulin dependent diabetes if D5W is required
Blood clotting disorders

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: IV Placebo

Patients will receive: Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure.

active comparator: IV N-acetylcysteine

Patients will receive: N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure.

Interventions

IV N-acetylcysteine

N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure

IV Placebo

Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure.

Primary outcome measure

Opioid Consumption 0-72 hours post-study medication [ Time Frame: 0-72 hours after study medication ]

Central Contacts and Locations

Central contacts

Haley Nitchie, MHA

843-792-1869 nitchie@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Sylvia Wilson, MD

843-792-2322 wilsosh@musc.edu

Principal Investigator:

Sylvia Wilson, MD

More Information

Sponsor

Medical University of South Carolina

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Keywords

hysterectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-10-14.