Intravenous Lidocaine in the Perioperative Setting and the Effects on Postoperative Pain and Bowel Function Following Cystectomy: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduced pain post-operatively using verbal analog score
研究概览
简要总结
Patients scheduled for a cystectomy at Charleston Area Medical Center (CAMC) will be enrolled into a randomized, double blinded clinical trial to assess if postoperative pain and ileus are reduced by perioperative intravenous lidocaine infusion versus placebo. The hypothesis is that patients receiving the lidocaine infusion will experience better pain control and ileus resolution. It is believed that lidocaine patients will also have less opioid requirement, less mortality, a shorter length of stay, less nausea /vomiting, and fewer adverse events.
详细描述
Design
The design will be a randomized, double blinded, single institute prospective study with patients undergoing Open or Robotic Assisted cystectomy procedures at Charleston Area Medical Center in Charleston, West Virginia. All patients following informed consent that meet the inclusion criteria are eligible to participate in the study.
Procedures and Protocol
This study will have two groups. Each group will follow a standardized post cystectomy protocol to reduce confounding factors in regards to postoperative management.
Study Group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient undergoing a cystectomy with an American Society of Anesthesiologists physical status classification (ASA) of 1 or 2.
排除标准
- •Any patients with a history of substance abuse, allergy to amides, and current treatment with antiarrhythmic medications (due to lidocaine being a class 1b antiarrhythmic agent) will be excluded.
- •Patients will also be excluded if they are pregnant or have a history of chronic pain syndrome, chronic bowel or liver dysfunction.
- •Patients with chronic opioid use, and therefore opioid tolerance, and history of opioid addiction will also be excluded due to likely increased opioid needs for equivalent pain control.
研究组 & 干预措施
Lidocaine Study Group
Intravenous Lidocaine for Cystectomy Procedures: During the surgery, the lidocaine infusion group will receive the lidocaine bolus (1.5mg/kg bolus followed by a 2mg/kg/h infusion) 30 minutes prior to skin incision and the infusion will continue until 60 minutes after skin closure.
干预措施: Cystectomy (Procedure)
Lidocaine Study Group
Intravenous Lidocaine for Cystectomy Procedures: During the surgery, the lidocaine infusion group will receive the lidocaine bolus (1.5mg/kg bolus followed by a 2mg/kg/h infusion) 30 minutes prior to skin incision and the infusion will continue until 60 minutes after skin closure.
干预措施: Lidocaine (Drug)
Placebo Study Group
Intravenous Saline for Cystectomy Procedures: During the surgery, patients will be randomized to the control group and receive a normal saline bolus 30 minutes prior to skin incision and the infusion will continue until 60 minutes after skin closure.
干预措施: Cystectomy (Procedure)
Placebo Study Group
Intravenous Saline for Cystectomy Procedures: During the surgery, patients will be randomized to the control group and receive a normal saline bolus 30 minutes prior to skin incision and the infusion will continue until 60 minutes after skin closure.
干预措施: Saline (Drug)
结局指标
主要结局
Reduced pain post-operatively using verbal analog score
时间窗: 108 hours after surgery
Use verbal analog score to assess patients pain and compare between study and control groups. This will determine if patients in the lidocaine study arm experience less pain than those in the placebo group.
Time until Ileus resolution
时间窗: 108 hours after surgery
Time to ileus resolution will be compared between study and control groups using the end of surgery time to the time of first bowl movement. This should determine if those in the lidocaine study arm experience quicker Ileus resolution compared to those in the placebo study arm.
次要结局
- Pain management during the first 24 hours after surgery using the American Pain Society Patient Outcome Questionnaire (APS-POQ-R)(24 hours post-operatively)
研究者
Samuel Deem, DO
Urology Surgeon
CAMC Health System