Paravertebral Block vs no Block in Open Pancreaticoduodenectomy: Prospective Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Mean Post-operative Pain Score
研究概览
简要总结
The purpose of this study is to compare intra and postoperative pain control between Paravertebral block vs no block in open pancreaticoduodenectomy. Length of stay, and complications will also be recorded. For this study the investigator plans to randomize to obtain objective data for clinical decisions and improve patient outcomes. Following surgery patients in both groups, data will be collected from the first 48 hours after surgery and at discharge.
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
- 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
- •Patients willing and have signed consent.
- •Nonpregnant adults undergoing open pancreaticoduodenectomy via standard upper midline incision without contraindications to para vertebral block (PVB)
排除标准
- •Not able or unwilling to sign consent.
- •Currently pregnant or lactating.
- •Patients with chronic pain, requiring daily opiate use at time of surgery.
- •Patients intolerant of opiates, NSAIDS, acetaminophen or local anesthetics.
研究组 & 干预措施
Paravertebral Block Pre Procedure
Subject will receive a preoperative paravertebral block only
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Mean Post-operative Pain Score
时间窗: First 48 hours after surgery
The VAS is a 11-item questionnaire assessing pain. Using a scale of 0 = no pain to 10 = worst pain. Total scores range from 0 - 110, lower scores indicating lower pain and higher scores indicating greater pain. The average score across the 11 questions was calculated for each subject using the minimum and maximum values reported for each subject across the 11 questions.
次要结局
- Hospital Length of Stay(Approximately 4-6 days post surgery)
- Number of Subjects With a Bowel Obstruction(Approximately 2-4 days)
研究者
John A. Stauffer
Principal Investigator
Mayo Clinic