Paravertebral Block Versus General Anesthesia for Major Abdominal Surgery in Elderly: a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of patients admitted to Intensive Care Unit (ICU)
研究概览
简要总结
Elderly patients are usually presented with higher risk for developing cardiopulmonary complications after general anesthesia (GA). Bilateral paravertebral block (PVB) has been associated with favorable outcomes in patients undergoing ventral hernia repair. Hence, elderly patients undergoing major abdominal surgery may benefit from PVB anesthetic technique.
详细描述
Introduction
Elderly patients are usually presented with higher risk for developing cardiopulmonary complications after general anesthesia (GA). The risk of adverse events in elderly patients increases with the combination of intraoperative fentanyl, opioid premedication and neuromuscular blockers. Bilateral paravertebral block (PVB) has been associated with favorable outcomes in patients undergoing ventral hernia repair. Hence, elderly patients may benefit from PVB anesthetic technique.
The objective of the study is to compare PVB versus GA for elderly patients undergoing major abdominal surgery. The primary outcome measure is admission to the Intensive Care Unit (ICU). The secondary objective is postoperative analgesic consumption.
Methods
Following approval from the Institutional Review Board, 60 patients aged 70 years or older scheduled to undergo major abdominal surgery from May 2016 till December 2020 will be included in the study. Consent will be obtained from the patients or their family member. Patients will be divided into two groups. Group I will receive PVB while group II will receive GA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 70 years or older admitted for major abdominal surgery
排除标准
- •Known history of allergic reactions to local anesthesia
- •Neurological disorders
- •Bleeding disorders
- •Infection at site of injection.
研究组 & 干预措施
PVB group
Patients will receive nerve stimulator guided paravertebral block
干预措施: Paravertebral block (Drug)
PVB group
Patients will receive nerve stimulator guided paravertebral block
干预措施: Major abdominal surgery (Procedure)
GA group
Patients will receive general anesthesia
干预措施: General anesthesia (Drug)
GA group
Patients will receive general anesthesia
干预措施: Major abdominal surgery (Procedure)
结局指标
主要结局
Number of patients admitted to Intensive Care Unit (ICU)
时间窗: 48 hours postoperatively
次要结局
- Hemodynamic stability measured through Mean Arterial Pressure (mmHg)(48 hours postoperatively)
- Hemodynamic stability measured through heart rate (beats per minute)(48 hours postoperatively)
研究者
Zoher Naja
Chairperson of Anesthesia and Pain Management Department
Makassed General Hospital