NCT01836614

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 1 Year – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Disorders

Interventions

Type	Name	Description
DRUG	Lidocaine	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-03-01
• Completion: 2018-04-01
• First posted: 2013-04-22
• Last updated: 2016-03-08

Locations

1 site across 1 country: United States