Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Pancreatectomy

Treatments: Drug: Placebo D5W; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02623803

15-003955

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Treatment group

Active Comparator group

Description:

lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.

Treatment:

Drug: Lidocaine

Control group

Placebo Comparator group

Description:

placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.

Treatment:

Drug: Placebo D5W