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

Primary Purpose

Colorectal Disorders

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Disorders

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lidocaine

Saline

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Length of stay in hospital following abdominal surgery
The primary outcome measure will be to monitor the length of stay in hospital following abdominal surgery.

Secondary Outcome Measures

Postoperative pain scores
Study staff will monitor patients pain every 15 minutes in the PACU and record documentation every 4 hours while on the floor.
Cumulative morphine consumption
Staff will document how much morphine a patient uses post-operatively after abdominal surgery.
Incidences of opioid adverse-effects
Study staff will monitor nursing notes for respiratory depression, sedation, nausea and vomiting
Time to passage of flatus and bowel movement
Study staff will review nursing notes for time of passage of flatus and first bowel movement.
End-tidal Sevoflurane in operating room throughout surgery
Serial lidocaine levels for pharmacokinetics and safety levels
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
Pro- and anti-inflammatory cytokine measurements: IL-6, IL-8, IL-10, IL-1RA
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
Genetic variants
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

Full Information

First Posted
April 8, 2013
Last Updated
March 7, 2016
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT01836614
Brief Title
Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients
Official Title
Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Study was closed due to recommendations of performing a PK study first.
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
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
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
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 Measure Information:
Title
Length of stay in hospital following abdominal surgery
Description
The primary outcome measure will be to monitor the 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
Secondary Outcome Measure Information:
Title
Postoperative pain scores
Description
Study staff will monitor patients pain every 15 minutes in the PACU and record documentation every 4 hours while on the floor.
Time Frame
participants will be followed post-op, average 5 days
Title
Cumulative morphine consumption
Description
Staff will document how much morphine a patient uses post-operatively after abdominal surgery.
Time Frame
participants will be followed post-op, average 5 days
Title
Incidences of opioid adverse-effects
Description
Study staff will monitor nursing notes for respiratory depression, sedation, nausea and vomiting
Time Frame
participants will be followed post-op, average 5 days
Title
Time to passage of flatus and bowel movement
Description
Study staff will review nursing notes for time of passage of flatus and first bowel movement.
Time Frame
participants will be followed post-op, average 5 days
Title
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
Title
Serial lidocaine levels for pharmacokinetics and safety levels
Description
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
Time Frame
participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
Title
Pro- and anti-inflammatory cytokine measurements: IL-6, IL-8, IL-10, IL-1RA
Description
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
Time Frame
participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
Title
Genetic variants
Description
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
Time Frame
participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Smokey J Clay, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17197840
Citation
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Citation
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19843784
Citation
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Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients

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