Quadratus Lumborum Block (QLB) With and Without Dexamethasone: the Effect on Postoperative Pain and Recovery After Laparoscopic Nephrectomy
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- opiate consumption
研究概览
简要总结
There are ca 900 new cases of kidney cancer in Finland/year. The curative therapy for kidney cancer is partial or total nephrectomy depending on the localization and the size of tumor. Main of these operations are laparoscopic.
Epidural analgesia is considered as most effective for the treatment of postoperative pain after open nephrectomy, but after laparoscopic operation parenteral and enteral opioids combined with paracetamol (acetaminophen) usually offer adequate postoperative pain relief. However, the need for opioids postoperatively may be high and side effects, such as sedation and nausea, are common. On the other hand epidural analgesia has some contraindications and risks for serious complications. Nevertheless, inadequately treated acute postoperative pain is considered as one of the main risk factors for persistent postoperative pain.
Recently quadratus lumborum block (QLB) has gained popularity in the treatment of postoperative pain after various surgeries in the area from hip to mamilla. It is more beneficial than other peripheral blocks, since it covers also the visceral nerves. A single shot QLB has reported to last up to 48 hours.
Perineural dexamethasone added to local anesthetic has been reported to prolong the duration of analgesia of the perineural nerve block, but it's effect on the duration of QLB is not known.
90 kidney cancer patients with planned laparoscopic nephrectomy aging 18-85 will be recruited based on a power calculation. The primary outcome measure is the postoperative cumulative opioid consumption. Secondary outcomes are acute pain (NRS scale), nausea, vomiting, mobilisation and long term outcomes such as quality of life and persistent pain.
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)
盲法说明
Patients are randomized and allocated in blocks of nine to either placebo or QLB with dexamethasone or QLB without dexamethasone group
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with renal cancer coming to the laparoscopic radical nephrectomy
排除标准
- •age under 18y or over 85y
- •diabetes type 1 with complications
- •no co-operation or inadequate finnish language skills
- •persistent pain for other reason
- •severe hepatic insufficiency or paracetamol (acetaminophen) is contraindicated for other reason
- •any type of steroid in regular use
- •oxycodone contraindicated
- •medications changing notably paracetamol (acetaminophen) and/or ropivacaine metabolism in regular use
研究组 & 干预措施
QLB without dexamethasone
Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and isotonic natriumchloride solution (NaCl 0,9%) 0,4 ml
干预措施: Ropivacaine Hydrocloride (Drug)
QLB with dexamethasone
Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and dexamethasone 5 mg/ml 0,4 ml
干预措施: Dexamethasone sodium phosphate (Drug)
QLB with dexamethasone
Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and dexamethasone 5 mg/ml 0,4 ml
干预措施: Ropivacaine Hydrocloride (Drug)
QLB without dexamethasone
Single sided US-guided QLB using ropivacaine 3,75 mg/ml 20 ml and isotonic natriumchloride solution (NaCl 0,9%) 0,4 ml
干预措施: Sodium Chloride 9mg/mL (Drug)
Placebo
Single sided US-guided QLB using isotonic natriumchloride solution (NaCl 0,9%) 20,4 ml
干预措施: Sodium Chloride 9mg/mL (Drug)
结局指标
主要结局
opiate consumption
时间窗: 24 hours
cumulative opiate consumption postoperatively
次要结局
- opiate consumption(72 hours)
- mobilization(72 hours)
- postoperative nausea(72 hours)
- pain score(7 days)
- persistent pain(12 months)
- functional query(12 months)
- quality of life(12 months)
- postoperative vomiting(72 hours)