NAC vs Placebo on Opioid Use for Hysterectomy
Recruiting
Phase 3
Interventional Study
Hysterectomy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 240 (estimated)
- Sponsor
- Medical University of South Carolina · Other
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About This Trial
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.
Trial Locations
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Eligibility 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, whee…
Contacts