Clinical trial NCT02623803: Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies
Official title: Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-12-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Overall Pain in Postoperative Period
timeFrame: baseline - arrival at the PACU
measure: Opioid Consumption
timeFrame: up to 4 hours post-operatively
Secondary outcomes:
measure: Pain at Rest
timeFrame: baseline - arrival at the PACU
measure: Pain With Coughing
timeFrame: baseline - arrival at the PACU
measure: Overall Pain
timeFrame: 30 minutes after arrival to PACU
measure: Pain at Rest
timeFrame: 30 minutes after arrival to PACU
measure: Pain With Coughing
timeFrame: 30 minutes after arrival to PACU
measure: Overall Pain
timeFrame: approximately 12 hours post-operatively
measure: Pain at Rest
timeFrame: approximately 12 hours post-operatively
measure: Pain With Coughing
timeFrame: approximately 12 hours post-operatively
measure: Overall Pain
timeFrame: post-operative day 1 at 1am
measure: Pain at Rest
timeFrame: post-operative day 1 at 1 am
measure: Pain With Coughing
timeFrame: post-operative day 1 at 1 am
measure: Overall Pain
timeFrame: post-operative day 1 at 1 pm
measure: Pain at Rest
timeFrame: post-operative day 1 at 1 pm
measure: Pain With Coughing
timeFrame: post-operative day 1 at 1 pm
measure: Length of Time to First Flatus
timeFrame: up to 3 weeks postoperatively
measure: Length of Time to First Bowel Movement
timeFrame: up to 3 weeks postoperatively
measure: Total Opioid Consumption
timeFrame: up to 24 hours post-operatively
measure: Quality of Recovery
timeFrame: Day 15 post-operatively
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Elird Bojaxhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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