A Trial Evaluating the Impact of N-acetylcysteine on Opioid Use in Patients Undergoing a Hysterectomy Procedure
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Undergoing elective laparoscopic or robotic, full, or partial hysterectomy procedure
• 18 years of age and older
Locations
United States
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Contact Information
Primary
Haley Nitchie, MHA
nitchie@musc.edu
843-792-1869
Time Frame
Start Date: 2023-11-30
Estimated Completion Date: 2026-12-09
Participants
Target number of participants: 240
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Medical University of South Carolina