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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
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.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
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.
Time frame: participants will be followed for the duration of hospital stay, an average of 1 week
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: participants will be followed post-op, average 5 days
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
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
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Time frame: 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
Time frame: 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
Time frame: participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively