Clinical trial NCT01836614: Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients
Official title: Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Colorectal Disorders
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2013-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* patient without Peripherally Inserted Central Catheter or other central access with contraindication to inhalation induction
* family history or know patient susceptibility to malignant hyperthermia

Primary outcomes:
measure: Length of stay in hospital following abdominal surgery
timeFrame: participants will be followed for the duration of hospital stay, an average of 1 week
Secondary outcomes:
measure: Postoperative pain scores
timeFrame: participants will be followed post-op, average 5 days
measure: Cumulative morphine consumption
timeFrame: participants will be followed post-op, average 5 days
measure: Incidences of opioid adverse-effects
timeFrame: participants will be followed post-op, average 5 days
measure: Time to passage of flatus and bowel movement
timeFrame: participants will be followed post-op, average 5 days
measure: End-tidal Sevoflurane in operating room throughout surgery
timeFrame: participants will be measured until the end of the OR case, on average 6 hours
measure: Serial lidocaine levels for pharmacokinetics and safety levels
timeFrame: participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
measure: Pro- and anti-inflammatory cytokine measurements: IL-6, IL-8, IL-10, IL-1RA
timeFrame: participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
measure: Genetic variants
timeFrame: participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Smokey J Clay, MD
role: PRINCIPAL_INVESTIGATOR
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