Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Control After Endoscopic Prostatectomy - Double Blinded, Placebo-controlled, Randomised Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Opioid consumption following prostatectomy
研究概览
简要总结
Laparoscopic prostatectomy (LP) is characterized by substantial tissue trauma, despite its minimally -invasive approach. Although postoperative pain intensity is lower when compared to open procedures, the use of opioids is common. Retrospective review of available LP cases revealed that although analgesic demand varied, nearly all of our LP patients required opioids postoperatively. Bilateral Quadratus Lumborum Block (QLB), being one of relatively new features of regional anesthesia, offers good analgesia of abdominal wall, with the potential for control of visceral pain. This study was established to evaluate its effectiveness in alleviating pain after radical prostatectomy in a double - blind, placebo - controlled manner.
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)
盲法说明
Solution used for block (local anesthetic or placebo) is known to anesthetist not involved in patient's care.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA status less or equal 3
- •Scheduled for transperitoneal or extraperitoneal endoscopic prostatectomy
- •Able to understand information provided and to sign the informed consent for participation in the study
排除标准
- •known allergy to local anesthetics and opioids
- •infection in the area of block placement
- •known chronic use of opioids, gabapentinoids and tricyclic antidepressants
- •mental inability to understand the principles and rules of patient-controlled analgesia pump
研究组 & 干预措施
QLB with 0,9% NaCl
干预措施: Qadratus Lumborum Block (Procedure)
QLB with 0,9% NaCl
干预措施: 30 milliliters of 0.9% NaCl (Drug)
QLB with 0,375% ropivacaine
干预措施: Qadratus Lumborum Block (Procedure)
QLB with 0,375% ropivacaine
干预措施: 30 milliliters of 0.375% Ropivacaine (Drug)
结局指标
主要结局
Opioid consumption following prostatectomy
时间窗: 24 hours
Oxycodone consumption with Patient-Controlled Analgesia pump
次要结局
- Opioids - related complications(24 hours)
- Pain score(24 hours)
- Time to first dose of opioid(24 hours)
研究者
Bartosz Horosz, MD
MD
Centre of Postgraduate Medical Education