NAC vs Placebo on Opioid Use for Hysterectomy

A Trial Evaluating the Impact of N-acetylcysteine on Opioid Use in Patients Undergoing a Hysterectomy Procedure

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.

Study Overview

• Status: Recruiting
• Conditions: Hysterectomy
• Intervention / Treatment: Drug: IV Placebo; Drug: IV N-acetylcysteine

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Haley Nitchie, MHA; Phone Number: 843-792-1869; Email: nitchie@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Sylvia Wilson, MD; Phone Number: 843-792-2322; Email: wilsosh@musc.edu
      • Principal Investigator: Sylvia Wilson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: 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.; Other Names: Placebo
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.	Drug: 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; Other Names: NAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption 0-72 hours post-study medication	72-hour post-medication opioid consumption.	0-72 hours after study medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	Using a Visual Analog Scale from 0-100, patients will report pain scores from 0-72 hours post-medication. A lower pain score means a better outcome.	Study medication start to 72 hours post-study medication

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative opioid consumption	Total morphine milligram equivalents administered during the procedure	during the procedure (up to 12 hours)
postoperative anesthesia care unit (PACU) opioid consumption	Total morphine milligram equivalents administered in the PACU	PACU Arrival until PACU Discharge up to 52 weeks
non-opioid analgesic administration	Total other pain medication administered during the procedure and in PACU	Anesthesia start until PACU discharge up to 52 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Sylvia Wilson, M.D., Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): December 9, 2026

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: hysterectomy
• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Sulfur Compounds; Organic Chemicals; Amino Acids; Cysteine; Amino Acids, Sulfur; Acetylcysteine
• Other Study ID Numbers: Pro00130489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No