Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients
Overview
- Phase
- Phase 1
- Intervention
- Lidocaine
- Conditions
- Colorectal Disorders
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Locations
- 1
- Primary Endpoint
- Length of stay in hospital following abdominal surgery
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Arms & Interventions
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
Intervention: Lidocaine
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.
Intervention: Lidocaine
Outcomes
Primary Outcomes
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 Outcomes
- 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(participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively)
- Postoperative pain scores(participants will be followed post-op, average 5 days)
- Pro- and anti-inflammatory cytokine measurements: IL-6, IL-8, IL-10, IL-1RA(participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively)
- Genetic variants(participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively)
- Cumulative morphine consumption(participants will be followed post-op, average 5 days)
- Incidences of opioid adverse-effects(participants will be followed post-op, average 5 days)
- Time to passage of flatus and bowel movement(participants will be followed post-op, average 5 days)