Hysterectomy Clinical Trial
Official title:
A Trial Evaluating the Impact of N-acetylcysteine on Opioid Use in Patients Undergoing a Hysterectomy Procedure
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
United States,
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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