Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies

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 Overview

• Status: Completed
• Conditions: Pancreatectomy
• Intervention / Treatment: Drug: Lidocaine; Drug: Placebo D5W

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment group; 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
Placebo Comparator: Control group; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Elird Bojaxhi, MD, Mayo Clinic

Publications and helpful links

General Publications

• Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.
• Wheatley RG, Schug SA, Watson D. Safety and efficacy of postoperative epidural analgesia. Br J Anaesth. 2001 Jul;87(1):47-61. doi: 10.1093/bja/87.1.47. No abstract available.
• Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983.
• Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
• Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available.
• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.
• Herroeder S, Pecher S, Schonherr ME, Kaulitz G, Hahnenkamp K, Friess H, Bottiger BW, Bauer H, Dijkgraaf MG, Durieux ME, Hollmann MW. Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial. Ann Surg. 2007 Aug;246(2):192-200. doi: 10.1097/SLA.0b013e31805dac11. Erratum In: Ann Surg. 2009 Apr;249(4):701. Dijkgraaf, Omarcel G W [corrected to Dijkgraaf, Marcel G W].
• Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.
• Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375.
• BARTLETT EE, HUTSERANI O. Xylocaine for the relief of postoperative pain. Anesth Analg. 1961 May-Jun;40:296-304. No abstract available.
• Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
• Senagore AJ, Delaney CP, Mekhail N, Dugan A, Fazio VW. Randomized clinical trial comparing epidural anaesthesia and patient-controlled analgesia after laparoscopic segmental colectomy. Br J Surg. 2003 Oct;90(10):1195-9. doi: 10.1002/bjs.4223.
• Rimback G, Cassuto J, Tollesson PO. Treatment of postoperative paralytic ileus by intravenous lidocaine infusion. Anesth Analg. 1990 Apr;70(4):414-9.
• Wallin G, Cassuto J, Hogstrom S, Linden I, Faxen A, Rimback G, Hedner T. Effects of lidocaine infusion on the sympathetic response to abdominal surgery. Anesth Analg. 1987 Oct;66(10):1008-13.
• DE CLIVE-LOWE SG, DESMOND J, NORTH J. Intravenous lignocaine anaesthesia. Anaesthesia. 1958 Apr;13(2):138-46. doi: 10.1111/j.1365-2044.1958.tb08045.x. No abstract available.
• Gower ST, Quigg CA, Hunt JO, Wallace SK, Myles PS. A comparison of patient self-administered and investigator-administered measurement of quality of recovery using the QoR-40. Anaesth Intensive Care. 2006 Oct;34(5):634-8. doi: 10.1177/0310057X0603400514.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: November 16, 2015
• First Submitted That Met QC Criteria: December 3, 2015
• First Posted (Estimate): December 8, 2015

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 15-003955