NAC vs Placebo on Opioid Use for Hysterectomy
Purpose
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.
Condition
- Hysterectomy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Charleston, South Carolina 29425
More Details
- Status
- Recruiting
- Sponsor
- Medical University of South Carolina