Actively Recruiting
A Trial Evaluating the Impact of N-acetylcysteine on Opioid Use in Patients Undergoing a Hysterectomy Procedure
Led by Medical University of South Carolina · Updated on 2025-10-14
240
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of intravenous n-acetylcysteine (NAC) compared to a placebo on opioid use in females aged 18 and older undergoing laparoscopic or robotic, partial or full hysterectomy procedures. This phase 3 trial aims to understand how NAC affects pain and opioid consumption after surgery. Participants will be randomly assigned to receive either NAC at a dose of 150 mg/kg (up to 15,000 mg) or a placebo solution (0.45% NaCl or D5W) administered through an IV for 60 minutes at the start of their hysterectomy procedure. The study uses a triple-blind design, meaning patients, healthcare providers, and researchers will not know who receives NAC or placebo during the treatment. During the 72 hours following the procedure, participants will report their pain levels and record any pain medications taken. Researchers will closely monitor opioid consumption and pain scores to assess the effects of NAC. The study includes careful safety monitoring and will continue until December 2026.
CONDITIONS
Brief Title
NAC vs Placebo on Opioid Use for Hysterectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing elective laparoscopic or robotic, full, or partial hysterectomy procedure
- 18 years of age and older
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of the surgical procedure
Participants receive either an IV infusion of N-acetylcysteine or a placebo during their hysterectomy procedure.
1 infusion at the start of the procedure
Duration - 72 hours after study medication
Participants are monitored for opioid use and pain scores after the procedure.
Visits during the 72 hours post-infusion to assess opioid use and pain
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
H
Haley Nitchie, MHA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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