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:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2025-12-24 @ 3:34 PM
NCT ID:
NCT02179892
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients undergoing scheduled abdominal surgery at Emory University Hospital or Emory University Hospital Midtown
* Patients willing and able to provide written informed consent
Exclusion Criteria:
* Patients less than 18 years of age, since Exparel has not been studied in this age group
* Patients who are pregnant or lactating, since Exparel has not been shown to be safe in this population, and because of potential drug transfer to child
* Patients with uncontrolled diabetes since dexamethasone may cause hyperglycemia
* Patients with liver dysfunction, since bupivacaine is hepatically metabolized
* Patients with renal failure, since bupivacaine is renally excreted, defined as requiring hemodialysis or renal replacement therapy
* Patients with allergy to one of the study drugs
* Patients with local infection, which may be exacerbated by dexamethasone
* Patients with significant opioid tolerance, defined as taking at least 60 mg oral morphine per day, 3 mg oral oxycodone per day, 25 mcg/hr fentanyl patch, 25 mg oral oxymorphone per day, 8 mg of oral hydromorphone per day or an equianalgesic dose of another opioid for one week or longer
* Patients with known coagulopathy, since bleeding risk is higher Patients who are getting neuraxial anesthesia for surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02179892
Study Brief:
Protocol Section:
NCT02179892