Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies

Mayo Clinic48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pancreatectomy

Interventions

LidocaineDRUG

Placebo D5WDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

Mayo Clinic Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline - arrival at the PACU

Opioid Consumption

Total opioid consumption in PACU converted to morphine equivalents in mg.

Time frame: up to 4 hours post-operatively

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Day 15 post-operatively