Comparing the Efficacy of Epidural and Quadratus Lumborum Analgesia After Open Nephrectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Total opioid consumption
研究概览
简要总结
This study aims to assess if Quadratus Lumborum (QL) blocks are non-inferior to epidural analgesia for pain control and opioid consumption through the third postoperative day in patients having open partial nephrectomy. Patients satisfying all inclusion and exclusion criteria will be randomized in a 1:1 ratio to either epidural catheter or QL catheter.
详细描述
QL blocks with a single shot and catheters infusions may be an alternative to epidural analgesia. However, the relative efficacy, safety, and cost of the two approaches remain unclear.
Epidural analgesia is frequently used as a component of multimodal analgesia for thoracic and abdominal surgery. QL block has been introduced recently as a component of multimodal analgesia for lower thoracic and abdominal surgery. In general, insertion of QL catheter is easier and safer than insertion of epidural catheters. QL catheter management is also less complicated than epidural analgesia (fewer catheter displacements and less hemodynamic compromise) and decreases the level of complexity in postoperative care. Our hypothesis is that the subcostal QL approach with a continuous catheter is non-inferior to epidural analgesia for pain control and opioid consumption in patients having open partial nephrectomy procedure.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults having for open unilateral partial nephrectomy surgery.
排除标准
- •Intolerance or allergy to opioids
- •Previous radical nephrectomy surgery/midline incision
- •Contraindication to epidural analgesia
- •Contraindications to QL block
- •Chronic pain characterized by: i.Opioids use for more than 30 consecutive days within the 3 preoperative months at the dose equal or greater than equivalent of 15 mg of morphine ii.Abdominal pain for more than 6 months, present most days of the week-
结局指标
主要结局
Total opioid consumption
时间窗: Arrival to post anesthesia care unit until 72 hours after surgery
Total IV morphine-equivalent doses used, started postoperatively at the time of arrival to post anesthesia care unit until 72 hours after surgery.
Postoperative pain
时间窗: Arrival to post anesthesia care unit until 72 hours after surgery
Time-weighted average verbal rating scale for pain until 72 hours after operation as a time-weighted average, based on nursing assessments at four-hour intervals. The verbal rating scale ranges from 0 to 10, with 0 indicating no pain and 10 indicating worst pain imaginable. Time-weighted average pain is defined as the sum of each time interval between two adjacent pain score measurements multiplied by the average of the two corresponding pain scores divided by the time interval between the first and last pain scores.
次要结局
- Duration of postoperative hospitalization(From the date of surgery to hospital discharge, assessed up to 12 months.)
- Patient Global Assessment(Three days after surgery)
- Doses of antiemetic medications administered(Arrival to post anesthesia care unit until the third day after surgery)
- Episodes of hypotension(Arrival to post anesthesia care unit until the third day after surgery)