Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies

Phase 4

Completed

Conditions: Pancreatectomy

Interventions: Drug: Placebo D5W
Drug: Lidocaine

Registration Number: NCT02623803

Lead Sponsor: Mayo Clinic

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo D5W	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 group	Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
Overall Pain in Postoperative Period	baseline - arrival at the PACU	Overall pain will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Opioid Consumption	up to 4 hours post-operatively	Total opioid consumption in PACU converted to morphine equivalents in mg.

Secondary Outcome Measures

Name	Time	Method
Pain at Rest	post-operative day 1 at 1 pm	Pain at rest will be measured at post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Pain With Coughing	post-operative day 1 at 1 pm	Pain with coughing will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Quality of Recovery	Day 15 post-operatively	This questionnaire is a short 15 question form that measures the quality of a subject's postoperative recovery. The scale is ranked from 0 to 10, where 0 is a poor response and 10 is an excellent response.
Length of Time to First Flatus	up to 3 weeks postoperatively	Time of first instance of flatus will be measured as the number of days post operatively for bowel function to return.
Total Opioid Consumption	up to 24 hours post-operatively	Total amount of opioids converted to morphine equivalents in mg administered in the first 24 hours after surgery.
Overall Pain	post-operative day 1 at 1 pm	Overall pain will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
Length of Time to First Bowel Movement	up to 3 weeks postoperatively	Time of first instance of a bowel movement will be measured as the number of days post operatively for bowel function to return.