Pilot Study: A Non-Inferiority Trial of the Analgesic Effect of Paravertebral Analgesia to Epidural Analgesia for the Management of Post-Operative Pain After Thoracotomy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Analgesic Effect
研究概览
简要总结
Paravertebral analgesia is non-inferior to epidural analgesia for pain control and superior to epidural analgesia in terms of the main complication of hypotension.
详细描述
There is some evidence that paravertebral analgesia is similar to epidural analgesia in efficacy but superior in maintenance of blood pressure. This is a double blind, randomized control trial comparing paravertebral catheters to epidural catheters for the management of post thoracotomy analgesia. Both groups will undergo placement of a pre-induction epidural catheter as well as a surgically placed paravertebral catheter. Patients will also receive PCA morphine. The primary outcome will be daily morphine use measured in milligrams. The co-primary outcome will be time spent with a systolic blood pressure below 90mmHg. Outcomes will be measured during the first five postoperative days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Open thoracotomy
- •Age > 18 yo
- •Able to use a patient controlled analgesia device
排除标准
- •Previous thoracotomy
- •Previous spine surgery
- •Chronic pain condition
- •Ongoing narcotic use
- •Prior narcotic abuse
- •Active chest infection
- •Chest trauma
- •Anticoagulation
- •Other contraindication to epidural catheter placement
- •Allergy to local anesthetic or narcotic
研究组 & 干预措施
Epidural Catheter 0.2% ropivacaine
Patients will receive an infusion of 0.2% ropivacaine at a range of 0-10 mL/hr through an epidural catheter. They will also receive an infusion of saline at a rate of 0-10 mL/hr through a paravertebral catheter.
干预措施: Epidural Catheter 0.2% ropivacaine (Drug)
Paravertebral Catheter 0.4% ropivacaine
Patients will receive an infusion of 0.4% ropivacaine at a range of 0-10mL/hr through a paravertebral catheter. They will also receive an infusion of saline at a range of 0-10mL/hr through an epidural catheter.
干预措施: Paravertebral Catheter 0.4% ropivacaine (Drug)
结局指标
主要结局
Analgesic Effect
时间窗: At postoperative day 5
Total cumulative dose of morphine equivalent narcotics.
次要结局
- Hypotension(At postoperative day 5)
研究者
Sadeesh Srinathan, MD
Assistant Professor- Department of Thoracic Surgery
University of Manitoba