Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Percutaneous Nephrolithotomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Total morphine consumption
研究概览
简要总结
Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain, despite a multimodal analgesic regime.
We hypothesize that active (ropivacaine) transmuscular quadratus lumborum (TQL) block will significantly reduce postoperative opioid consumption and pain following PNL operation compared with placebo (saline) TQL block.
The aim of this study is to investigate the effect of ultrasound-guided (USG) TQL block concurrent with a multimodal analgesic regime compared to the multimodal analgesic regime alone (and placebo TQL block) in a randomized and placebo controlled design.
详细描述
Patients undergoing percutaneous nephrolithotomy (PNL) suffer from acute postoperative pain, despite a multimodal analgesic regime, and the patients receive considerable amounts of long lasting opioids. For the patients this greatly increase the risk of experiencing the adverse effects of opioids.
The ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block is a single dosage of local anesthetic (LA) delivered in the plane between the psoas major muscle and the quadratus lumborum muscle. LA spreads cephalad into the thoracic paravertebral space to reach the somatic ventral rami (intercostal nerves) and the thoracic sympathetic trunk. The TQL block can reduce visceral pain and pain originating from the abdominal wall and has an expected duration of analgesic efficacy of 24 hours.
The aim of this study is to investigate the efficacy of the active USG TQL block together with the multimodal analgesic regime to reduce postoperative opioid consumption and pain compared to placebo USG TQL block and the multimodal analgesic regime in a randomized and placebo controlled design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Scheduled for elective PNL operation in general anaesthesia with propofol and remifentanil.
- •Received oral and written information about the trial Signed the informed consent American Society of Anesthesiologists (ASA) classification 1-3
排除标准
- •Cannot cooperate Does not speak or understand Danish Allergy towards drugs used in the trial Large daily consumption of opioids Known alcohol or drug abuse Difficulty or inability to visualize the relevant muscular or fascial structures necessary to perform the USG-TQL block Pregnancy
研究组 & 干预措施
Ropivacaine TQL block
Unilateral single shot ultrasound-guided TQL block with 30 ml of ropivacaine 0.75%
干预措施: Ropivacaine TQL block (Procedure)
Ropivacaine TQL block
Unilateral single shot ultrasound-guided TQL block with 30 ml of ropivacaine 0.75%
干预措施: Ropivacaine (Drug)
Ropivacaine TQL block
Unilateral single shot ultrasound-guided TQL block with 30 ml of ropivacaine 0.75%
干预措施: Ultrasound (Device)
Placebo TQL block
Unilateral single shot ultrasound-guided TQL block with 30 ml saline 0.9%
干预措施: Saline TQL block (Procedure)
Placebo TQL block
Unilateral single shot ultrasound-guided TQL block with 30 ml saline 0.9%
干预措施: Saline (Drug)
Placebo TQL block
Unilateral single shot ultrasound-guided TQL block with 30 ml saline 0.9%
干预措施: Ultrasound (Device)
结局指标
主要结局
Total morphine consumption
时间窗: 6 hours postoperatively
Morphine consumption in the first 6 hours postoperatively - data from PCA pump and patient medical record
次要结局
- Total morphine consumption(15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively)
- Pain score at sitting position (NRS 0-10/10)(15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively)
- Time to first ambulation - get out of bed(0-24 hours postoperatively)
- NRS score during application of the TQL block (NRS 0-10/10)(intraoperative)
- Opioid side effects (nausea, vomiting)(0-24 hours postoperatively)
- Pain score at rest (NRS 0-10/10)(15 min, 30 min, 1 h, 2h, 4h, 6h, 12h, 18h, 24 hours postoperatively)