NAC vs Placebo on Opioid Use for Hysterectomy

NCT06039566 | Recruiting Phase 3 FDA Drug

• 1 other identifier: Pro00130489
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

hysterectomy

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption 0-72 hours post-study medication

  72-hour post-medication opioid consumption.

  0-72 hours after study medication

Secondary Outcomes (1)

• Pain Scores

  Study medication start to 72 hours post-study medication

Other Outcomes (3)

• intraoperative opioid consumption

  during the procedure (up to 12 hours)

• postoperative anesthesia care unit (PACU) opioid consumption

  PACU Arrival until PACU Discharge up to 52 weeks

• non-opioid analgesic administration

  Anesthesia start until PACU discharge up to 52 weeks

Study Arms (2)

IV Placebo

PLACEBO COMPARATOR

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

IV N-acetylcysteine

ACTIVE COMPARATOR

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

Interventions

IV N-acetylcysteine DRUG

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

Also known as: NAC

IV N-acetylcysteine

IV Placebo DRUG

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.

Also known as: Placebo

IV Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Sylvia Wilson, M.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley Nitchie, MHA

CONTACT

843-792-1869; nitchie@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 15, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): November 25, 2026
• Study Completion (Estimated): December 9, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)