Improving Postoperative Pain Management With the Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Laparoscopic Hand-assisted Nephrectomy and Robot-assisted Partiel Nephrectomy: A Double Blind, Randomized, Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- opioid consumption
研究概览
简要总结
Patients with kidney cancer often undergo hand-assisted laparoscopic nephrectomy or Robot assisted partiel nephrectomy. The investigators performed a one-year retrospective study. the sudy revealed that 67% of the patients needed substantial amounts of opioids for postoperative pain management (PPM) in recovery despite a multimodal analgesic regime. In a prospective pilot study including ten laparoscopic hand-assisted nephrectomy, with severe postoperative pain the investigators found that bilateral Ultrasound-guided (USG) transmuscular quadratus lumborum (TQL) block substantially reduced pain and opioid consumption. This study aims to evaluate the effect on PPM of a bilateral USG TQL block compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blind
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
- •over 18 years
- •Kidney cancer
- •Have received thorough information, orally and in written
- •Signed the "Informed Consent" form on participation in the trial
排除标准
- •Inability to cooperate
- •Inability to speak and understand Danish both orally and written
- •Allergy to local anaesthetics or opioids
- •Daily intake of opioids
- •Local infection at the site of injection or systemic infection
- •Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
- •Known abuse of alcohol or medicine
- •Pregnancy
研究组 & 干预措施
TQL Ropivacaine(active)
Bilateral Single shot of ropivacaine 0.325% 30 mL. In total 60 mL of 0.325% ropivacaine
干预措施: Ropivacaine (Drug)
TQL saline (placebo)
Bilateral single shot of saline 0.9% 30 mL. in Total 60 mL of saline 0.9%
干预措施: Saline (Drug)
结局指标
主要结局
opioid consumption
时间窗: 12 hours postoperatively
Opioid consumption postoperatively: data from Patient Controlled Analgesia(PCA) pump and patient medical record).
次要结局
- opioid consumption(24 hours postoperatively)
- NRS score(12 hours postoperatively)
- NRS score at rest and activity(24 hours postoperatively)
- Opioid-related side effects(24 hours postoperatively)
- Patient satisfaction with application of the block. NRS(Immediately after application of the block)
- Ambulation(within 24 hours postoperatively)