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OpenTrials
Completed

NCT Number: NCT02623803

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.

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Key information

Conditions

Pancreatectomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lidocaine

Drug

Placebo D5W

Drug

Primary outcomes

  1. Overall Pain in Postoperative Period

    Time frame: 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.

  2. Opioid Consumption

    Time frame: up to 4 hours post-operatively

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

Secondary outcomes

  1. Pain at Rest

    Time frame: baseline - arrival at the PACU

    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.

  2. Pain With Coughing

    Time frame: baseline - arrival at the PACU

    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.

  3. Overall Pain

    Time frame: 30 minutes after arrival to PACU

    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.

  4. Pain at Rest

    Time frame: 30 minutes after arrival to PACU

    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.

  5. Pain With Coughing

    Time frame: 30 minutes after arrival to PACU

    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.

  6. Overall Pain

    Time frame: approximately 12 hours post-operatively

    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.

  7. Pain at Rest

    Time frame: approximately 12 hours post-operatively

    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.

  8. Pain With Coughing

    Time frame: approximately 12 hours post-operatively

    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.

  9. Overall Pain

    Time frame: post-operative day 1 at 1am

    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.

  10. Pain at Rest

    Time frame: post-operative day 1 at 1 am

    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.

  11. Pain With Coughing

    Time frame: post-operative day 1 at 1 am

    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.

  12. Overall Pain

    Time frame: 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.

  13. Pain at Rest

    Time frame: 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.

  14. Pain With Coughing

    Time frame: 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.

  15. Length of Time to First Flatus

    Time frame: 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.

  16. Length of Time to First Bowel Movement

    Time frame: 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.

  17. Total Opioid Consumption

    Time frame: up to 24 hours post-operatively

    Total amount of opioids converted to morphine equivalents in mg administered in the first 24 hours after surgery.

  18. Quality of Recovery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2015
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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