Multicentre Evaluation of a Novel Technique of Analgesia Following Open Liver Resection: Medial Open Transversus Abdominis Plane (MOTAP) Catheters
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Opioid consumption
研究概览
简要总结
Abdominal wall incisions used for liver surgeries are associated with significant postoperative pain and disability. Epidural analgesia is often contraindicated in these patients due to common bleeding problems. Furthermore, drugs such as acetaminophen and opioids are often inadequate and can lead to detrimental side-effects. Abdominal wall (AW) catheters can be placed during surgical closure along the incision line and can be used to administer local anesthetics for postoperative pain. The study is a multi-centre, double-blind, randomized controlled trial involving 120 patients undergoing elective liver surgery. Patients will be randomly assigned to AW catheter group treated with drug or control treated with saline. Treatment group will receive AW catheters with ropivacaine plus standard patient controlled analgesia (PCA). Control group will obtain AW with normal saline and no local anesthetics and PCA. Patients are followed for 6 months post-operatively for pain scores, side-effects, chronic pain and complications.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years age
- •Undergoing liver resection using a subcostal incision
排除标准
- •Patients unable to comprehend instructions, consent, or co-operate with pain assessment (including psychiatric disorders, pre-operative sedation, coma)
- •Allergy to any study medications
- •Patient not able to be extubated postoperatively for any clinical reason
- •Laparoscopic surgery
- •Co-existing epidural or intrathecal analgesia
- •Chronic pain disorders or on long-term opioid use
- •History of substance or alcohol abuse
- •Transplant donor liver resections
- •Patients with liver cirrhosis
研究组 & 干预措施
MOTAP Catheter with Saline and IV PCA
Control group will have saline 20cc of 0.9% normal saline injected into the catheters and then run at 5ml/hr for 72 hours
干预措施: saline and IV PCA (Procedure)
MOTAP catheter with ropivocaine and IV PCA
20cc of 0.2% ropivacaine will be injected in two equal divided doses through the two catheters then run at 5ml/hr for 72 hours
干预措施: ropivacaine + iv PCA (Procedure)
结局指标
主要结局
Opioid consumption
时间窗: PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay.
The primary endpoint is mean cumulative postoperative opioid consumption over the first two postoperative days (48 hours). Both intravenous PCA opioids and oral opioids will be recorded from the patient's medical records daily, converted to morphine equivalents, and compared between the two groups. The following information will be collected at regular intervals as a measure of the primary endpoints: Cumulative i.v. PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay.
次要结局
未报告次要终点