Prospective Post-market Evaluation of an Echogenic Catheter Used in a Peripheral Nerve Block Procedure
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visibility of catheter tip
研究概览
简要总结
Patients scheduled for mastectomy and suitable for paravertebral block will be randomized to one of 2 groups.
Group 1 will have the nerve block performed using a standard non-echogenic needle and catheter under ultrasound guidance. Group 2 will have the block performed using the control needle and an echogenic catheter, all under ultrasound (US) guidance.
The clinician will be blinded to the catheter type and will assess the quality of catheter visualisation of the US image during the procedure, along with adequacy of spread of local anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be block success rate and block quality. An assessment of the patient's pain levels after the procedure will also be conducted.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo breast surgery requiring use of a peripheral nerve block catheter for establishing a paravertebral block
- •Patients classified as ASA (American Society of Anesthesiologists) physical status I, II or III
- •Patients at least 18 years old
- •Patient is willing and able to provide informed consent for study participation
- •Patient has a good understanding of written and verbal English
排除标准
- •Patient with contraindications to regional anesthesia technique (e.g. allergy to local anesthetic or other medications used in study)
- •Patient with known coagulopathy
- •Patient whose target nerve cannot be seen with linear ultrasound probe in a pre-procedure scan. All patients who need a curvilinear probe to visualize the target nerve will be excluded from the study.
- •Patients having mastectomy and immediate reconstruction
结局指标
主要结局
Visibility of catheter tip
时间窗: Day 1, time of procedure
Demonstrate superior ultrasound visibility of the test catheter tip compared to the control, as graded by a blinded investigator
Visibility of entire catheter length
时间窗: Day 1, time of procedure
Demonstrate superior ultrasound visibility of the entire length of the test catheter compared to the control, as graded by a blinded investigator
次要结局
- Quality of the block(Day 1, time of procedure)
- Block failure rate(Day 1, time of procedure)