NAC vs Placebo on Opioid Use for Hysterectomy

Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06039566
• Other study ID #: Pro00130489
• Status: Recruiting
• Phase: Phase 3
• Start date: November 30, 2023
• Est. completion date: October 9, 2025

Study information

• Verified date: December 2023
• Source: Medical University of South Carolina
• Contact: Haley Nitchie, MHA
• Phone: 843-792-1869
• Email: nitchie[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 9, 2025
• Est. primary completion date: September 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hysterectomy

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	intraoperative opioid consumption	Total morphine milligram equivalents administered during the procedure	during the procedure (up to 12 hours)
Other	postoperative anesthesia care unit (PACU) opioid consumption	Total morphine milligram equivalents administered in the PACU	PACU Arrival until PACU Discharge up to 52 weeks
Other	non-opioid analgesic administration	Total other pain medication administered during the procedure and in PACU	Anesthesia start until PACU discharge up to 52 weeks
Primary	Opioid Consumption 0-72 hours post-study medication	72-hour post-medication opioid consumption.	0-72 hours after study medication
Secondary	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