Hysterectomy
Conditions
Keywords
hysterectomy
Brief 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.
Interventions
DRUGIV 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
DRUGIV 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.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption 0-72 hours post-study medication | 0-72 hours after study medication | 72-hour post-medication opioid consumption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | Study medication start to 72 hours post-study medication | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| intraoperative opioid consumption | during the procedure (up to 12 hours) | Total morphine milligram equivalents administered during the procedure |
| postoperative anesthesia care unit (PACU) opioid consumption | PACU Arrival until PACU Discharge up to 52 weeks | Total morphine milligram equivalents administered in the PACU |
| non-opioid analgesic administration | Anesthesia start until PACU discharge up to 52 weeks | Total other pain medication administered during the procedure and in PACU |
Countries
United States
Contacts
Primary ContactHaley Nitchie, MHA
Outcome results
None listed