A Randomized Comparison Between Conventional and Waveform-Confirmed Loss-of-Resistance for Thoracic Epidural Blocks
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Percentage of Patients With Successful Epidural Blocks
研究概览
简要总结
In the investigators' institution, the failure rate for thoracic epidural blocks is 23.1%. This stems from the prevalence of trainee operators coupled with the non-specific nature of loss-of-resistance. In the current randomized trial, we will set out to compare conventional and epidural waveform analysis-confirmed loss-of-resistance. The investigators' research hypothesis is that loss-of-resistance combined with epidural waveform analysis will decrease the failure rate of thoracic epidural blocks.
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)
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
- •the patients undergoing thoracic epidural catheter insertion for thoracic and abdominal surgery or rib fractures with American Society of Anesthesiologists (ASA) classification 1-3 and body mass index between 18 and 35
排除标准
- •adults who are unable to give their own consent
- •coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets ≤ 100, or International Normalized Ratio ≥ 1.4)
- •renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine ≥ 100)
- •hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases ≥ 100)
- •allergy to local anesthetic (LA)
- •pregnancy
- •prior surgery in the thoracic spine
研究组 & 干预措施
Conventional loss-of-resistance
Waveform-confirmed loss-of-resistance
干预措施: Waveform-confirmed loss-of-resistance (Procedure)
结局指标
主要结局
Percentage of Patients With Successful Epidural Blocks
时间窗: up to 15 minutes after the procedure
Fifteen minutes after the LA injection, a blinded observer will apply ice to the T1-L4 dermatomes and assess the epidural block. The criterion standard for success will be the presence of an epidural block (defined as a block to ice in at least 2 dermatomes bilaterally). If the operators cannot thread the catheter after 2 attempts, epidural blocks will considered failures.
次要结局
未报告次要终点
研究者
De QH Tran
Associate professor
Montreal General Hospital