Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies

Study Overview
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Brief Summary
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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.

Official Title
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Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies

Conditions
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Pancreatectomy

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Placebo D5W


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>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. | Drug: Lidocaine<br> <br> |
| Placebo Comparator: Control group<br>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. | Drug: Placebo D5W<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Pain in Postoperative Period | 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. | baseline - arrival at the PACU | 
| Opioid Consumption | Total opioid consumption in PACU converted to morphine equivalents in mg. | up to 4 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at Rest | Pain will be measured at rest 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. | baseline - arrival at the PACU | 
| Pain With Coughing | Pain with coughing 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. | baseline - arrival at the PACU | 
| Overall Pain | Overall pain will be measured 30 minutes after 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. | 30 minutes after arrival to PACU | 
| Pain at Rest | Pain at rest will be measured 30 minutes after 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. | 30 minutes after arrival to PACU | 
| Pain With Coughing | Pain with coughing will be measured 30 minutes after 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. | 30 minutes after arrival to PACU | 
| Overall Pain | Overall pain will be measured approximately 12 hours post-operatively 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. | approximately 12 hours post-operatively | 
| Pain at Rest | Pain at rest will be measured approximately 12 hours post-operatively 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. | approximately 12 hours post-operatively | 
| Pain With Coughing | Pain with coughing will be measured approximately 12 hours post-operatively 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. | approximately 12 hours post-operatively | 
| Overall Pain | Overall pain will be measured on post-operative day 1 at 1am 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. | post-operative day 1 at 1am | 
| Pain at Rest | Pain at rest will be measured on post-operative day 1 at 1 am 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. | post-operative day 1 at 1 am | 
| Pain With Coughing | Pain with coughing will be measured on post-operative day 1 at 1 am 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. | post-operative day 1 at 1 am | 
| Overall Pain | 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. | post-operative day 1 at 1 pm | 
| Pain at Rest | 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. | post-operative day 1 at 1 pm | 
| Pain With Coughing | 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. | post-operative day 1 at 1 pm | 
| Length of Time to First Flatus | Time of first instance of flatus will be measured as the number of days post operatively for bowel function to return. | up to 3 weeks postoperatively | 
| Length of Time to First Bowel Movement | Time of first instance of a bowel movement will be measured as the number of days post operatively for bowel function to return. | up to 3 weeks postoperatively | 
| Total Opioid Consumption | Total amount of opioids converted to morphine equivalents in mg administered in the first 24 hours after surgery. | up to 24 hours post-operatively | 
| Quality of Recovery | 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. | Day 15 post-operatively |