Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies

Completed · Phase 4 · Has a placebo group

Conditions studied: Pancreatectomy

In brief

The purpose of this study is to evaluate if a lidocaine infusion will provide benefit to pancreatectomy patients in regards to analgesia and return of bowel function.

Key facts

Study ID

NCT02623803

Run by

Mayo Clinic

People needed

48

Starts

2016-01-01

Expected to finish

2018-02-01

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Mayo Clinic Florida — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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