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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Disorders

Intervention / Treatment
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* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>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<br>* 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.<br>|
| Placebo Comparator: Saline<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | participants will be followed for the duration of hospital stay, an average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | participants will be followed post-op, average 5 days | 
| Cumulative morphine consumption | Staff will document how much morphine a patient uses post-operatively after abdominal surgery. | participants will be followed post-op, average 5 days | 
| Incidences of opioid adverse-effects | Study staff will monitor nursing notes for respiratory depression, sedation, nausea and vomiting | participants will be followed post-op, average 5 days | 
| Time to passage of flatus and bowel movement | Study staff will review nursing notes for time of passage of flatus and first bowel movement. | participants will be followed post-op, average 5 days | 
| End-tidal Sevoflurane in operating room throughout surgery |  | participants will be measured until the end of the OR case, on average 6 hours | 
| 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 | participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively | 
| 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 | participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively | 
| 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 | participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively |