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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06039566
Other study ID # Pro00130489
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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