Comparing N-acetylcysteine and placebo for pain management after hysterectomy
A Trial Evaluating the Impact of N-acetylcysteine on Opioid Use in Patients Undergoing a Hysterectomy Procedure
This study is testing if giving N-acetylcysteine during surgery can help women manage pain better and use less opioid medication after having a hysterectomy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06039566 on ClinicalTrials.gov |
What this trial studies
This clinical trial will enroll women aged 18 and older who are undergoing laparoscopic or robotic hysterectomy procedures. Participants will be randomly assigned to receive either intravenous N-acetylcysteine or a placebo during the first hour of their surgery. Following the procedure, patients will report their pain levels and any pain medication they have taken at various time points. The goal is to evaluate the effectiveness of N-acetylcysteine in reducing opioid use post-surgery.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older scheduled for elective laparoscopic or robotic hysterectomy.
Not a fit: Patients with a history of adverse reactions to acetylcysteine or those with active asthma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced opioid consumption and improved pain management for patients undergoing hysterectomy.
How similar studies have performed: Other studies have shown promise in using N-acetylcysteine for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Sylvia Wilson, M.D. — Medical University of South Carolina
- Study coordinator: Haley Nitchie, MHA
- Email: nitchie@musc.edu
- Phone: 843-792-1869
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.