The Role of Epidural Opioids in Pain Management After Abdominal Surgery in Adult Patients - a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Postoperative analgesia
研究概览
简要总结
It is unclear whether addition of opioids to epidural solutions for postoperative analgesia is beneficial. In this multicenter randomized double-blinded trial, we aim to test the primary hypothesis that epidural solutions containing only bupivacaine are as effective as solutions containing both bupivacaine and fentanyl in promoting analgesia in patients recovering from open abdominal surgery. We also aim to assess the incidence of epidural-induced hypotension, the difference in patient-reported opioid side-effects between the two groups. If we demonstrate no clinically important difference between the two interventions, clinicians will be able to substantially reduce the amount of opioids patients receive during their postoperative recovery, and potentially decrease the associated high incidence of opioid adverse effects in post-surgical patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •18-85 years old
- •Undergoing open abdominal surgery (including colorectal, intestinal, gastric, pancreatic, hepatobiliary, urological, or gynecological surgery)
- •For which a clinical decision has been made to provide epidural analgesia preoperatively and extending to the post-operative period
- •Anticipated hospitalization of at least 2 nights
排除标准
- •Known allergy to bupivacaine or fentanyl
- •Chronic liver disease, defined as cirrhosis, portal hypertension, or variceal bleeding
- •Patients under chronic alpha-blocking agents for hypertension
- •Clinical contraindications to epidural introduction, as judged by the anesthesia provider (thrombocytopenia, un-interrupted anticoagulation, clinically-significant atrio-ventricular conduction block, etc.)
- •Pregnant women
研究组 & 干预措施
Bupivacaine + Fentanyl
Epidural solution containing 0.1% bupivacaine and 3 mcg/ml of fentanyl in normal saline
干预措施: Bupivacaine (Drug)
Bupivacaine
Epidural solution containing 0.1% bupivaacaine in normal saline
干预措施: Bupivacaine (Drug)
Bupivacaine + Fentanyl
Epidural solution containing 0.1% bupivacaine and 3 mcg/ml of fentanyl in normal saline
干预措施: Fentanyl (Drug)
结局指标
主要结局
Postoperative analgesia
时间窗: 48 postoperative hours
A joint outcome of the difference in average pain score and a ratio of opioid consumption (in mg morphine equivalents) between the 2 study groups
次要结局
- Clinically significant postoperative hypotension(48 postoperative hours)
研究者
Barak Cohen, MD
Senior Anesthesiologist
Tel-Aviv Sourasky Medical Center