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临床试验/NCT03729635
NCT03729635已完成不适用

Ultrasound-guided Pectoral-intercostal Fascial Plane Block for Patients With Severe Pain After Coronary Artery Bypass Graft Surgery: A Feasibility Study

University of British Columbia2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Feasibility of PIFB in reduction of PSP following Sternotomy

研究概览

简要总结

Pain along the sternum following opening of the chest cavity, also known as post-sternotomy pain (PSP), is a common complication after heart surgery that is associated with several negative side effects. Unfortunately, an effective and safe treatment has not yet been discovered for PSP. However, recently a regional anesthesia technique called the pecto-intercostal fascial block (PIFB) was found to be associated with improved pain relief for breast surgery. The investigators plan to assess the feasibility of using PIFB as an effective and safe treatment for PSP.

详细描述

Post-sternotomy pain (PSP) is a common complication after cardiac surgery, occurring up to 49% of patients at rest according to one prospective study. In addition to decreased patient satisfaction, PSP has been associated with adverse post-operative events including delirium, hypertension, tachycardia, arrhythmias, respiratory complications and persistent post-surgical pain.

While most PSP can be effectively managed with opioids, non-steroidal anti-inflammatory drugs (NSAIDs) or central neuraxial blockades, these analgesia techniques also carry a high incidence of adverse effects. The use of opioid analgesics, for example, can contribute to respiratory depression, nausea, and delirium. While NSAIDs can be effective analgesics, they are also associated with postoperative kidney injury after cardiac surgery, a significant risk factor for mortality. Further, intrathecal or epidural techniques have a significant failure rate, and may be associated with severe hypotension, and devastating consequences such as neuraxial hematoma or infection. As such, alternative methods that are effective and safe for treating severe PSP remain elusive.

Peripheral regional anesthetic techniques have been demonstrated to reduce opioid consumption and may also provide improved respiratory mechanics. The pecto-intercostal fascial block (PIFB) was recently described in a descriptive letter by de la Torre and colleagues for anesthesia during breast surgery. In this technique, local anesthetic is infiltrated into the fascial plane between pectoralis major and the intercostal muscles lateral to the sternum to anesthetize the anterior cutaneous branches of the intercostal nerves. While the authors do state improved analgesia for breast surgery in their experience with use of this block, specific outcomes such as pain scores or opioid consumption are not reported.

The anterior cutaneous branches of the T2 to T6 intercostal nerves are thought to be the major sensory innervators of the sternum.

Using the same PIFB described above, the investigators have recently treated a patient successfully with severe PSP after CABG. To our knowledge, there is limited literature describing the use of this block for treatment of PSP. The investigators plan to conduct a prospective feasibility study to 1) assess the feasibility of using PIFB to reduce PSP in post-coronary bypass and/or valvular surgery patients and 2) obtain subjective data with regard to patient satisfaction and reduction in opioid consumption use that may help guide future, well-powered, randomized studies. 3) Describe any adverse outcomes following PIFB.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing a CABG and/or valve Surgery.
  • Extubated and on no assisted ventilation
  • NPRS equal to or greater than 5 related to sternal pain despite standard treatment
  • Aged 19-80
  • American Society of Anesthesiologists Physical Status Classification System 1 to 4 (ASA I-IV)
  • Provided written informed consent
  • Body Mass Index < 35 kg/m^2
  • Patient weight equal to or greater than 50 kg
  • CAM negative and RASS of +1 (restless) to -2 (light sedation)

排除标准

  • A known history or allergy, sensitivity, or any other form of reaction to amide-type local anesthetics.
  • Suspected inability to comply with study procedures, including language difficulties, or medical history and/or concomitant disease, as judged by the investigator.
  • A neurological and/or vascular condition which may preclude eligibility for peripheral nerve blockade as judged by the investigator.
  • Coagulopathy
  • Previous inclusion in this study.
  • Participation in other clinical studies during this study or in the 14 days prior to admission to this study.
  • Neuromuscular disease
  • Thoracotomy
  • Mini-Sternotomy

研究组 & 干预措施

PIFB performed to treat PSP

Experimental

Pectoral-intercostal fascial plane block (PIFB) is performed on patients with severe post-sternotomy pain (PSP) after coronary artery bypass graft surgery (CABG).

干预措施: Pectoral-intercostal fascial plane block (PIFB) (Procedure)

结局指标

主要结局

Feasibility of PIFB in reduction of PSP following Sternotomy

时间窗: Baseline to 30 minutes post-block completion

Defined as successful reduction of NPRS by 2 or more points

次要结局

  • Blood pressure(Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block))
  • Vasopressor medications administered(Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block))
  • Numeric pain rating score (NPRS)(Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block))
  • Duration of block(Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block))
  • Loss of Sensation(30 minutes post block)
  • Opioid and analgesic use(24 hours after block or until discharge from Cardiac Surgery Intensive Care Unit (CSICU) (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block))
  • Most Painful Site(30 minutes 12 hours and 24 hours post block if still in CSICU)
  • Dose of Vasopressor medications administered(Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block))
  • Supplemental Oxygen (O2)(Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block))
  • Heart rate(Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block))
  • Respiration Rate (RR)(Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block))
  • Peripheral Capillary Oxygen (SPO2)(Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block))
  • Confusion Assessment Method (CAM)(12 hours and 24 hours post block (if still in CSICU))

研究者

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

Christopher Prabhakar

Clinical Assistant Professor

University of British Columbia

研究点 (2)

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