跳至主要内容
临床试验/NCT03868917
NCT03868917Unknown不适用

Comparison of Ultrasound-guided Approach and Ultrasound-guided Approach Combined With Pressure Measurement Technique to Thoracic Paravertebral Block for Open Thoracotomy

Yeungnam University College of Medicine2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
72
试验地点
2
主要终点
visual analogue scale for pain (VAS) at 2 hour after the arrival of postanesthetic care unit (PACU)

研究概览

简要总结

Posterolateral thoracotomies are among the most painful procedures of surgery and may cause severe postoperative chest pain and impaired respiratory performance. Paravertebral block (PVB) is an established method of administering postoperative analgesia for thoracic procedures. PVB blocks the somatic and sympathetic nervous systems and is placed by injecting a local anesthetic (LA) into the paravertebral space where the nerve and its branches are located after exiting the intervertebral foramen. But previous study showed 5-10% of failure rate in PVB using ultrasound machine. Pressure measurement during needle advancement could improve reliability of correct needle placement. When the needle tip reaches paravertebral space, there is a sudden lowering of pressures due to respiratory cycle. Therefore, sensitivity and specificity could be improved and correct needle placement become objective and reproducible when PVB using ultrasound is combined with pressure measurement during needle advancement.

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
19 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for elective thoracotomy
  • ASA status 1,2

排除标准

  • Inability to provide adequate informed consent
  • Any contraindication to the placement of thoracic paravertebral catheters
  • Unstable vertebral and transverse process fractures
  • Any chronic painful conditions or preoperative opioid use Any chronic painful conditions or preoperative opioid use
  • Coagulation abnormalities or expectation to be on therapeutic anticoagulants postoperatively
  • Allergy to any of the drugs/agents used in study protocol
  • Altered mental status or emergency surgery
  • Comorbid conditions such as sepsis, unstable angina, congestive heart failure

研究组 & 干预措施

ultrasound group

No Intervention

The participants have continuous thoracic paravertebral block performed using only the ultrasound approach.

pressure measurement group

Experimental

The participants have continuous thoracic paravertebral block performed using the ultrasound-guided approach combined with pressure measurement techniqueduring needle advancement.

干预措施: thoracic paravertebral block using pressure measurement technique (Procedure)

结局指标

主要结局

visual analogue scale for pain (VAS) at 2 hour after the arrival of postanesthetic care unit (PACU)

时间窗: 2 hour after the arrival of PACU

VAS score is measured at 2 hour after a patient arrives in PACU. The pain VAS is a unidimensional measure of pain intensity. The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme (no pain 0, maximal pain 100).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sangjin Park

professor

Yeungnam University College of Medicine

研究点 (2)

Loading locations...

相似试验