Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT03907033
Eligibility Criteria:
INCLUSION CRITERIA
1\. Women 18-85 who will be having an outpatient vaginal hysterectomy with or without concurrent prolapse repair surgery at Mayo Clinic Hospital in Arizona
EXCLUSION CRITERIA
1. Known history of hepatic (liver) disease as evidenced by an AST or ALT that is greater than normal values
2. Known history of renal (kidney) disease as evidenced by a serum creatinine that is greater than normal values
3. Known history of prolonged QT (QTc greater than 500 m/s)
4. Opiate tolerance as noted by daily use of greater than 20 mg morphine daily oral equivalents per day for a minimum of 1 month prior to surgery
5. Allergy or contraindication to amide local anesthetics, celecoxib, ketorolac, NSAIDs, acetaminophen, gabapentin, sulfa drugs, or ondansetron
6. Allergy to both oxycodone and hydromorphone
7. Patients with acute gastrointestinal bleed that has occurred less than 6 months prior to study enrollment
8. Adults lacking the ability to consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03907033
Study Brief:
Protocol Section:
NCT03907033