Paravertebral Block With Versus Without Clonidine for Patients Undergoing Ventral Hernia Repair: A Prospective Double-blinded Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hemodynamic stability recorded from electrocardiogram and pulse oximeter
研究概览
简要总结
Paravertebral block (PVB) combined with light intravenous sedation was associated with a short hospital stay, less post-operative nausea and vomiting and reduced analgesic consumption compared to general anesthesia for ventral hernia repair. Given the effectiveness of PVB in the ventral hernia repair, it would be beneficial to study the effect of PVB with versus without clonidine in elderly patients.
Patients will be randomly allocated to one of 2 groups with 30 patients in each, using the sealed envelope technique. Group one will receive PVB with clonidine while group 2 will receive PVB with placebo.
详细描述
Introduction
Paravertebral block (PVB) showed to be successful in both children and adults. It has been reported to be an excellent pain reliever and it reduces post-operative nausea and vomiting, in patients undergoing breast surgery. PVB has proven to be very useful as a regional anesthetic technique when it comes to surgeries involving lumbar and thoracic dermatome. It was shown that the PVB combined with light intravenous sedation was associated with a short hospital stay, less post-operative nausea and vomiting (PONV) and reduced analgesic consumption compared to general anesthesia for ventral hernia repair. Given the effectiveness of PVB in the ventral hernia repair, it would be beneficial to study the effect of PVB with versus without clonidine in elderly patients.
Objectives:
The primary objective of this study is to compare the hemodynamic stability in a ventral hernia repair using paravertebral block with clonidine versus the PVB without clonidine.
The secondary objectives include a comparison of PONV and postoperative analgesic consumption.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for ventral hernia repair whose age is 65 years and older
- •and with ASA greater or equal to 2
排除标准
- •History of allergic reactions to local anesthetics
- •Bleeding diatheses
- •Spinal abnormality
结局指标
主要结局
Hemodynamic stability recorded from electrocardiogram and pulse oximeter
时间窗: within the first 48 hours after surgery
Compare the hemodynamic stability between the two groups
次要结局
- Postoperative nausea and vomiting recorded via questionnaire(within the first 48 hours after surgery)
- Postoperative analgesic consumption recorded via questionnaire(within the first 48 hours after surgery)
研究者
Zoher Naja
Chairperson of Anesthesia and Pain Management Department
Makassed General Hospital