A Randomized Comparison Between Epidural Waveform Analysis Through the Needle Versus the Catheter for Thoracic Epidural Blocks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Performance time of block
研究概览
简要总结
Epidural waveform analysis (EWA) provides a simple confirmatory adjunct for loss-of-resistance (LOR): when the needle/catheter tip is correctly positioned inside the epidural space, pressure measurement results in a pulsatile waveform. Epidural waveform analysis can be carried out through the tip of the needle or the catheter. In this randomized trial, the objective is to compare epidural waveform analysis through the needle (EWA-N) and through the catheter (EWA-C) for thoracic epidural blocks.
详细描述
The epidural space is most commonly identified with loss-of-resistance (LOR). Though sensitive Epidural waveform analysis (EWA) provides a simple confirmatory adjunct for LOR. When the needle (or catheter) is correctly positioned inside the epidural space, pressure measurement at its tip results in a pulsatile waveform synchronized with arterial pulsations Currently, there exist two different methods for EWA. Since local anesthetic (LA) is administered through the catheter, pressure transduction through its tip ensures that it is properly positioned inside the epidural space prior to LA injection. Alternately, EWA can be performed through the needle prior to blind advancement of the epidural catheter.
Thus, in this randomized trial, the aim is to compare epidural waveform analysis through the needle (EWA-N) and through the catheter (EWA-C) for thoracic epidural blocks. The hypothesis is that, compared to EWA-C, EWA-N will result in a shorter performance time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcome assessment will not be present during the performance of the epidural block and waveform analysis.
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
- 是
入选标准
- •age between 18 and 80 years
- •American Society of Anesthesiologists classification 1-3
- •body mass index between 20 and 35
排除标准
- •adults who are unable to give their own consent
- •coagulopathy
- •renal failure
- •hepatic failure
- •allergy to local anesthetic
- •pregnancy
- •prior surgery in the thoracic spine
研究组 & 干预措施
EWA through the needle
EWA through the needle group, 5 mL of normal saline are injected through the epidural needle after the occurrence of LOR. The needle is subsequently connected to the pressure transducer (leveled with the heart) via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations.
干预措施: EWA through the needle (Device)
EWA through the catheter
EWA through the catheter group, the epidural catheter is advanced 5 cm beyond the needle tip after the occurrence of LOR. Subsequently, the operator injects 5 mL of normal saline through the catheter and the latter is connected to the pressure transducer via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations.
干预措施: EWA through the catheter (Device)
结局指标
主要结局
Performance time of block
时间窗: From skin infiltration until local anesthetic administration through the needle or catheter, up to 60 minutes
temporal interval in minutes between skin infiltration and local anesthetic administration through the epidural catheter (after obtaining a satisfactory waveform either through the needle or through the catheter depending on randomized group assignment).
次要结局
- Incidence of successful epidural block(15 minutes after the administration of local anesthetic through the epidural catheter)
- Procedural pain during epidural block assessed by the numeric rating scale(From the performance of the epidural block until induction of general anesthesia, up to 2 hours)
- Local anesthetic consumption(once a day from the arrival at PACU or until catheter removal, up to 5 days)
- Postoperative pain related to surgical incision assessed by the numeric rating scale(twice a day from the arrival at PACU or until catheter removal, up to 5 days)
- Breakthrough opioid consumption (if required)(once a day from the arrival at PACU or until catheter removal, up to 5 days)
- Incidence of adverse events(Once a day from catheter insertion until removal, up to 5 days)
研究者
De Tran
Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre