NCT02523443进行中（未招募）3 期
A Prospective Randomized Controlled Clinical Trial of Patient Controlled Epidural Analgesia Versus Intravenous Patient Controlled Analgesia for Post-Operative Pain Control in Patients Undergoing Elective Open Liver Resection
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 231
- 试验地点
- 4
- 主要终点
- ability to detect a 2-point NRS scale difference
研究概览
简要总结
The purpose of this study is to learn whether patient-controlled epidural analgesia (PCEA) is a better method for managing pain after liver resection compared to patient-controlled analgesia (IV PCA). Currently, the standard pain control method for liver resection patients is IV PCA. There is not enough data on how epidural (PCEA) relieves pain and movement on a day to day basis after liver resection.
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
- •Adults (age 18 years or older) who are able to provide informed consent.
- •Patients undergoing open elective liver resection for primary liver pathology (benign or malignant) or secondary metastatic liver disease, including patients undergoing concomitant surgical procedures (such as colorectal resection or debulking procedures), with no contraindication to the insertion of an epidural catheter (localized infection, septicemia, or pre-operative coagulopathy).
排除标准
- •Patients with a history of documented anaphylaxis or contraindication to any of the study medications or standardized intra-operative medications. These include dilaudid, fentanyl, and bupivacaine.
- •Patients with pain at rest or with movement measured by NRS >
- •Patients receiving high dose opioids on a chronic basis (greater than or equivalent to 60mg of morphine per day).
- •Patients with severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 <50%.
- •Patients with significant cognitive impairment or documented psychologic impairment.
- •Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myelo-opticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 100,000/μL, or evidence of infection at potential epidural site.
- •Cirrhotic patients. When incidentally discovered intra-operatively, patients will be excluded from the study and replaced, but will be followed for primary and secondary endpoints.
- •Patients with poor performance status preoperatively such that they are unable to walk up two flights of stairs.
- •Patients taking any opioid agonist/antagonist medication (i.e. Buprenorphine)
研究组 & 干预措施
PCEA during and after surgery
Experimental
general anesthesia with post-operative thoracic epidural analgesia with a standard demand pump
干预措施: PCEA (Other)
IV PCA after surgery
Active Comparator
general anesthesia with post-operative IV PCA with a standard demand pump
干预措施: IV PCA (Other)
结局指标
主要结局
ability to detect a 2-point NRS scale difference
时间窗: 1 year
The primary endpoint assesses differences in pain control between PCEA and IV PCA after a "get up and go" test performed on POD2 during pain rounds, evaluated using a NRS pain score.
次要结局
未报告次要终点
研究者
研究点 (4)
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