A Randomized Comparison Between Ultrasound Guided Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Morphine consumption over 24 hours
研究概览
简要总结
The nerves from lumbar plexus (LP) are the current target to achieve analgesia after a total hip arthroplasty (THA). Lumbar plexus block (LPB) is an alternative that provides optimal postoperative analgesia. However, many adverse effects and complications have been reported due to its proximity to vital structures. Because of these shortcomings, an alternative to block the LP nerves is required.
In a recent trial suprainguinal Fascia Iliaca Block (SFIB) was reported to provide reliable analgesia in THA. SFIB may carry a lower risk profile, however, no study has compared the efficacy of LPB and SFIB in this setting.
Thus, this randomized trial is set out to compare US guided LPB and SFIB for analgesia after THA. The hypothesis is that both blocks would result in similar postoperative opioid (morphine) consumption at 24 hours and, therefore, designed the study as an equivalence trial.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •American Society of Anesthesiologists classification 1-3
- •Body mass index between 20 and 35 (kg/m2)
排除标准
- •Adults who are unable to give their own consent
- •Pre-existing neuropathy (assessed by history and physical examination)
- •Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- •Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
- •Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
- •Allergy to local anesthetics (LAs) or morphine
- •Pregnancy
- •Prior surgery in the corresponding side of the lumbar o suprainguinal area
- •Chronic pain syndromes requiring opioid intake at home
结局指标
主要结局
Morphine consumption over 24 hours
时间窗: 24 hours post block
Total morphine consumption over 24 hours post block
次要结局
- Performance time(2 hours after surgery)
- Postoperative static pain at 12 hours after block(12 hours after the block)
- Postoperative static pain at 3 hours after block(3 hours after the block)
- Postoperative static pain at 24 hours after block(24 hours after the block)
- Postoperative dynamic pain at 3 hours after block(3 hours after the block)
- Postoperative dynamic pain at 24 hours after block(24 hours after the block)
- Number of needle passes(2 hours after surgery)
- Postoperative dynamic pain at 6 hours after block(6 hours after the block)
- Block assessment at 3 hours(3 hours after the block)
- Length of hospital stay(7 days after surgery)
- Block assessment at 6 hours(6 hours after the block)
- Incidence of Inability to perform physiotherapy(24 hours after the block)
- Surgical duration(4 hours)
- Readiness to discharge(4 days after surgery)
- Postoperative static pain at 6 hours after block(6 hours after the block)
- Postoperative dynamic pain at 12 hours after block(12 hours after the block)
- Time until first morphine demand(48 hours after the block)
- Block assessment at 24 hours(24 hours after the block)
- Incidence of block related adverse events(3 hours after block)
- Incidence of opioid related adverse events(48 hours after block)
- Postoperative static pain at 48 hours after block(48 hours after the block)
- Postoperative dynamic pain at 48 hours after block(48 hours after the block)
研究者
Daniela Bravo Advis
Assistant Professor
University of Chile