Volume Versus Concentration: a Prospective, Double Blind, Parallel Study to Compare the Clinical Effectiveness of Bilateral Quadratus Lumborum Blocks Using High Volume/Low Concentration or Low Volume/ High Concentration Local Anesthetic in Nephrectomies
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- pain control over the next 72 hours after surgery: Visual analogue scale
研究概览
简要总结
The quadratus lumborum has since 2016 become standard of care for abdominal and retroperitoneal surgeries at UPMC-Shadyside Hospital, replacing paravertebral blocks, and as part of a broader multimodal analgesia institutional Enhanced Recovery After surgery protocol. Since the first description of this technique, several approaches to and anatomic targets within the quadratus lumborum plane have been described although their mechanism of action, spread, and relative clinical effectiveness remain areas of some debate. What is proposed here is to investigate the relative clinical effectiveness of the relationship high volume/low concentration of local anesthetic or low volume/ high concentration of local anesthetic.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Randomization will be performed with software excel or spss. This randomization will be kept in an envelope. After the patient consents participation in the study, the investigator and the care provider will open the envelope and will perform the block according to the established in the randomization. The patient or the outcomes assessor will not have access to the volume and concentration used during the block. Will be the responsibility of investigators to keep in a safe place the information about the block received by the patients.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-90 years old
- •Patients undergoing nephrectomy
- •Body Mass Index 19-36
- •Male and Female
- •American Society of Anesthesiologist scale I, II, III
排除标准
- •Patient refusal
- •Non-English speaking or inability to participate in the study
- •Patients with coagulopathy or With International Normalized Ratio >1,5 the day of the surgery.
- •Chronic steroid use
- •Chronic pain
- •Chronic opiate use
研究组 & 干预措施
low volume High concentration group
1.Low Volume: 30 subjects randomized to Low Volume will receive bilateral Quadratus lumborum Block II. Each block of 0,75% ropivacaine x 15 mL + dexmedetomidine 0.4 mcg/kg (max dose 30 mcg for age <70, max dose 20 mcg for age >70) + dexamethasone 4 mg
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
high volume low concentration
2.High Volume: 30 subjects randomized to High Volume will receive bilateral Quadratus lumborum Block II. Each block of 0,375% ropivacaine x 30 mL + dexmedetomidine 0.4 mcg/kg (max dose 30 mcg for age <70, max dose 20 mcg for age >70) + dexamethasone 4 mg
干预措施: Ropivacaine 0.5% Injectable Solution (Drug)
结局指标
主要结局
pain control over the next 72 hours after surgery: Visual analogue scale
时间窗: 72 hours
Visual analogue scale (0-10) measurement
次要结局
- opioid consumption during the first 72 hours(72 hours)
- time of the first opioid consumption after surgery(24 hours)
- 100 feet walking(48 hours)
- presence or absence of muscular weakness after Quadratus lumborum type 2 block(24 hours)
研究者
Bruce Ben-David
Clinical Professor
University of Pittsburgh