Randomized Non-inferiority Trial of Continuous Thoracic Epidural Analgesia Versus Single Intercostal Nerve Block After Thoracotomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Pain Scores With Cough on First Postoperative Day
研究概览
简要总结
Unilateral intercostal nerve blocks provide pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects.
详细描述
In this study we will study to see if a single set of unilateral intercostal nerve blocks provides pain control as effectively as a continuous thoracic epidural, and will a lower incidence of side effects. Although the anesthesiologists involved in providing care for patients having thoracotomy incisions at St. Mary's Hospital are experts at placing thoracic epidural catheters, this study will attempt to show that a less technically challenging procedure done by surgeons intra-operatively can provide comparable pain relief.
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
- None
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
- •Age 18 years and older
- •Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection or pneumonectomy).
排除标准
- •Planned chest wall resection or abdominal incision and/or gastroesophageal surgery;
- •Current enrollment in another post-thoracotomy analgesic research protocol; pre-existing pain syndrome (such as fibromyalgia, complex regional pain syndrome or postherpetic neuralgia in a thoracic distribution);
- •Daily opioid therapy;
- •Current gabapentin or pregabalin therapy;
- •Allergy to any study medication; coagulation or infectious issues that would preclude epidural catheter placement;
- •Severe psychological disorders or inability to understand the study protocol; -Prisoners or other institutionalized individuals;
- •Severe hepatic, renal or cardiovascular disorders.
- •Women who are pregnant will not be included in this study.
研究组 & 干预措施
Epidural
In the epidural catheter (TEC) group, a thoracic epidural catheter will be placed at the level of T6-T8 and advanced 5 cm into the epidural space and a 3 ml test dose of lidocaine 1.5% will be administered before the induction of general anesthesia. Patients will be excluded from the study if the catheter cannot be placed. A bolus dose of 0.5 mg hydromorphone plus 4.5 ml 0.125% bupivacaine will be administered before surgical incision. An epidural infusion of 0.075% bupivacaine and 10 mcg/ml hydromorphone, prepared by the hospital pharmacy, will be started intraoperatively at a rate of 5 ml/hr.
干预措施: Epidural (Drug)
Intercostal bupivicaine (Exparel)
In the intercostal block (ICB) group, liposomal bupivacaine 1.3% (4 ml) will injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and one interspace above and below. In addition, liposomal bupivacaine 1.3 % (4 ml) will be injected at each of the chest tube exit sites. Thus, a total of 20 ml liposomal bupivacaine 1.3% (260 mg) will be administered.
干预措施: Intercostal Bupivicaine (Exparel) (Drug)
结局指标
主要结局
Pain Scores With Cough on First Postoperative Day
时间窗: In the morning (8 am) on first postoperative day
Pain with cough documented using the numerical rating scale pain scores (0-10)
Pain Scores With Cough on the Second Postoperative Day
时间窗: In the morning (8 am) on the second postoperative day
Pain with cough documented using the numerical rating scale pain scores (0-10). Zero indicates no pain, and 10 indicates the worst pain one could imagine.
次要结局
- Pain Scores at Rest in the Morning on the First Postoperative Day(Each morning for two days postoperative)
- Pain Scores at Rest on the Second Postoperative Day(Each morning for two days postoperative)