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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT02623803
Eligibility Criteria:
Inclusion Criteria:
* All adult patients undergoing elective open or laparoscopic total pancreatectomies and pancreatoduodenectomies (i.e., Whipple procedure), and participating in the Enhanced Recovery Protocol (ERP) at Mayo Clinic in Florida.
* Age 18 - 80 years old
* American Society of Anesthesiologist (ASA) class I - III
* BMI \< 40
* Ability to understand and read English
Exclusion Criteria:
* Not able or willing to sign consent
* Intolerance or allergy to opioids, NSAIDS, acetaminophen, or amide-type local anesthetics (i.e., lidocaine).
* History of epilepsy or currently receiving treatment for seizures
* Severe hepatic insufficiency (Child-Pugh Score C)
* Renal insufficiency (creatinine clearance less than 30 mL/minute)
* Advance heart failure (NY Heart failure stage 3 or greater; Ejection function \<30%)
* Cardiac arrhythmias: 2nd and 3rd degree heart block, sick sinus syndrome, symptomatic bradyarrhythmias, Wolff-Parkinson-White (WPW) syndrome, or Stokes-Adams syndrome; Left bundle branch block or bifascicular block; Not to exclude patients the following conditions unless clinical circumstance dictate: Atrial fibrillation or atrial fluTter; Presence of Implantable Cardioverter Defibrillator (ICD), or pacemakers
* Patients on anti-arrhythmic therapy (i.e., digoxin, amiodarone, flecainide, lidocaine, sotalol, etc.). Not to exclude patients on beta blockers (i.e., metoprolol, atenolol, etc.) unless clinical circumstance dictate
* Patients with active psychiatric disorders or cognitive dysfunction
* Pregnancy or lactating
* Enucleation, central, and distal pancreatectomy
* Opioid tolerance (defined as consumption of greater than 30 mg of oxycodone per day)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02623803
Study Brief:
Protocol Section:
NCT02623803