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

Cincinnati Children's Hospital Medical Center

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Colorectal Disorders

Treatments: Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01836614

CCHMC 2012-0674

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 to 15 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Lidocaine

Active Comparator group

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

Treatment:

Drug: Lidocaine

Saline

Placebo Comparator group

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.

Treatment:

Drug: Lidocaine