Perioperative Intravenous Lidocaine Infusion for Patients Undergoing Laparoscopic and Open Pancreatectomies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Opioid Consumption
研究概览
简要总结
The purpose of this study is to evaluate if a lidocaine infusion will provide benefit to pancreatectomy patients in regards to analgesia and return of bowel function.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients undergoing elective open or laparoscopic total pancreatectomies and pancreatoduodenectomies (i.e., Whipple procedure), and participating in the Enhanced Recovery Protocol (ERP) at Mayo Clinic in Florida.
- •Age 18 - 80 years old
- •American Society of Anesthesiologist (ASA) class I - III
- •BMI < 40
- •Ability to understand and read English
排除标准
- •Not able or willing to sign consent
- •Intolerance or allergy to opioids, NSAIDS, acetaminophen, or amide-type local anesthetics (i.e., lidocaine).
- •History of epilepsy or currently receiving treatment for seizures
- •Severe hepatic insufficiency (Child-Pugh Score C)
- •Renal insufficiency (creatinine clearance less than 30 mL/minute)
- •Advance heart failure (NY Heart failure stage 3 or greater; Ejection function <30%)
- •Cardiac arrhythmias: 2nd and 3rd degree heart block, sick sinus syndrome, symptomatic bradyarrhythmias, Wolff-Parkinson-White (WPW) syndrome, or Stokes-Adams syndrome; Left bundle branch block or bifascicular block; Not to exclude patients the following conditions unless clinical circumstance dictate: Atrial fibrillation or atrial fluTter; Presence of Implantable Cardioverter Defibrillator (ICD), or pacemakers
- •Patients on anti-arrhythmic therapy (i.e., digoxin, amiodarone, flecainide, lidocaine, sotalol, etc.). Not to exclude patients on beta blockers (i.e., metoprolol, atenolol, etc.) unless clinical circumstance dictate
- •Patients with active psychiatric disorders or cognitive dysfunction
- •Pregnancy or lactating
- •Enucleation, central, and distal pancreatectomy
- •Opioid tolerance (defined as consumption of greater than 30 mg of oxycodone per day)
研究组 & 干预措施
Treatment group
lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room.
干预措施: Lidocaine (Drug)
Control group
placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room.
干预措施: Placebo D5W (Drug)
结局指标
主要结局
Opioid Consumption
时间窗: up to 4 hours post-operatively
Total opioid consumption in PACU converted to morphine equivalents in mg.
Overall Pain in Postoperative Period
时间窗: baseline - arrival at the PACU
Overall pain will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.
次要结局
- Pain at Rest(post-operative day 1 at 1 pm)
- Pain With Coughing(post-operative day 1 at 1 pm)
- Quality of Recovery(Day 15 post-operatively)
- Length of Time to First Flatus(up to 3 weeks postoperatively)
- Total Opioid Consumption(up to 24 hours post-operatively)
- Overall Pain(post-operative day 1 at 1 pm)
- Length of Time to First Bowel Movement(up to 3 weeks postoperatively)
研究者
Elird Bojaxhi, M.D.
Principal Investigator
Mayo Clinic