Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Length of stay in hospital following abdominal surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Lidocaine (Drug)
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.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Length of stay in hospital following abdominal surgery
时间窗: 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.
次要结局
- 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)