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Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients

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ClinicalTrials.gov Identifier: NCT01836614
Recruitment Status : Withdrawn (Study was closed due to recommendations of performing a PK study first.)
First Posted : April 22, 2013
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
The purpose of this study is to determine if an intravenous lidocaine infusion (compared to placebo) intraoperatively will decrease time to return of bowel function postoperatively, decrease postoperative pain, diminish postoperative opioid requirement, minimize inflammatory markers and shorten time to discharge after colorectal surgery.

Condition or disease Intervention/treatment Phase
Colorectal Disorders Drug: Lidocaine Phase 1 Phase 2

Detailed Description:
Lidocaine is an amide local anesthetic that has analgesic and anti-inflammatory properties. Lidocaine infusion is a very useful pain medication that is underutilized to treat surgical, chronic, and cancer pain in children. The investigators propose to examine the perioperative use of lidocaine infusion in children undergoing colorectal surgery that involves an abdominal incision. The investigators plan to measure the following outcomes: length of stay in hospital following abdominal surgery, postoperative pain scores, cumulative morphine consumption, incidences of opioid adverse-effects: respiratory depression, sedation, nausea, vomiting, time to passage of flatus, time to first bowel movement and end-tidal Sevoflurane in operating room throughout surgery. The following laboratory values will be measured: serial lidocaine levels of pharmacokinetics and safety levels, Pro- and anti-inflammatory cytokine measurements: IL-6, IL-8, IL-10, IL-1RA and genetic variants.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients
Study Start Date : January 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine
The treatment group will receive a 1.5mg/kg intravenous lidocaine bolus over 10 minutes. The bolus will be followed by an intravenous lidocaine infusion of 1 mg/kg/hr. The infusion will be stopped after extubation prior to leaving the operating room or after 5 hours from the start of the infusion
Drug: Lidocaine
The treatment group will receive a 1.5mg/kg intravenous lidocaine bolus over 10 minutes after induction by means of an infusion pump. This bolus will be followed by an intravenous lidocaine infusion of 1 mg/kg/hr. The infusion will be stopped after extubation prior to leaving the operative room or after 5 hours from the start of the infusion, which ever comes first.

Placebo Comparator: Saline
The saline will be administered over an infusion pump over 10 minutes and followed by a bolus. The infusion will be stopped after extubation prior to leaving the operating room or after 5 hours from the start of the infusion.
Drug: Lidocaine
The treatment group will receive a 1.5mg/kg intravenous lidocaine bolus over 10 minutes after induction by means of an infusion pump. This bolus will be followed by an intravenous lidocaine infusion of 1 mg/kg/hr. The infusion will be stopped after extubation prior to leaving the operative room or after 5 hours from the start of the infusion, which ever comes first.




Primary Outcome Measures :
  1. Length of stay in hospital following abdominal surgery [ Time Frame: participants will be followed for the duration of hospital stay, an average of 1 week ]
    The primary outcome measure will be to monitor the length of stay in hospital following abdominal surgery.


Secondary Outcome Measures :
  1. Postoperative pain scores [ Time Frame: participants will be followed post-op, average 5 days ]
    Study staff will monitor patients pain every 15 minutes in the PACU and record documentation every 4 hours while on the floor.

  2. Cumulative morphine consumption [ Time Frame: participants will be followed post-op, average 5 days ]
    Staff will document how much morphine a patient uses post-operatively after abdominal surgery.

  3. Incidences of opioid adverse-effects [ Time Frame: participants will be followed post-op, average 5 days ]
    Study staff will monitor nursing notes for respiratory depression, sedation, nausea and vomiting

  4. Time to passage of flatus and bowel movement [ Time Frame: participants will be followed post-op, average 5 days ]
    Study staff will review nursing notes for time of passage of flatus and first bowel movement.

  5. End-tidal Sevoflurane in operating room throughout surgery [ Time Frame: participants will be measured until the end of the OR case, on average 6 hours ]
  6. Serial lidocaine levels for pharmacokinetics and safety levels [ Time Frame: participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively ]
    2 samples will be drawn at time of baseline IV placement Blood draw 0-3 minutes after bolus is complete Blood draw 9-15 minutes after the bolus is complete 2 blood samples will be drawn at the end of continuous infusion (either at end of surgery after extubation prior to leaving OR or after 5 hours from the start of the infusion) Blood draw 1 hour following the infusion Blood draw 2-3 hours following the end of the infusion 2 blood samples will be drawn 24 hours after surgery dependent of necessary labs

  7. Pro- and anti-inflammatory cytokine measurements: IL-6, IL-8, IL-10, IL-1RA [ Time Frame: participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively ]
    2 samples will be drawn at time of baseline IV placement Blood draw 0-3 minutes after bolus is complete Blood draw 9-15 minutes after the bolus is complete 2 blood samples will be drawn at the end of continuous infusion (either at end of surgery after extubation prior to leaving OR or after 5 hours from the start of the infusion) Blood draw 1 hour following the infusion Blood draw 2-3 hours following the end of the infusion 2 blood samples will be drawn 24 hours after surgery dependent of necessary labs

  8. Genetic variants [ Time Frame: participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively ]
    2 samples will be drawn at time of baseline IV placement Blood draw 0-3 minutes after bolus is complete Blood draw 9-15 minutes after the bolus is complete 2 blood samples will be drawn at the end of continuous infusion (either at end of surgery after extubation prior to leaving OR or after 5 hours from the start of the infusion) Blood draw 1 hour following the infusion Blood draw 2-3 hours following the end of the infusion 2 blood samples will be drawn 24 hours after surgery dependent of necessary labs



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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female children 1-15 years of age
  • ASA physical status 1-3
  • scheduled for colorectal surgery with abdominal incision
  • scheduled for complex urology surgical case

Exclusion Criteria:

  • ASA physical status > 3
  • postoperative intubation planned ahead of surgery
  • history of chronic use of opioid
  • history of hepatic,renal, or cardiac failure
  • history of organ transplant
  • BMI > 30
  • history of cardiac arrhythmia
  • history of long QT syndrome
  • history of allergic reaction to lidocaine or similar agents
  • history of seizure disorder
  • patient without Peripherally Inserted Central Catheter or other central access with contraindication to inhalation induction
  • family history or know patient susceptibility to malignant hyperthermia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836614


Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Smokey J Clay, MD Children's Hospital Medical Center, Cincinnati

Publications:

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01836614     History of Changes
Other Study ID Numbers: CCHMC 2012-0674
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action