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临床试验/NCT03176667
NCT03176667已完成不适用

Ultrasound Guided Erector Spinae Plane Block in Patients Undergoing Video-assisted Thoracoscopic Surgery (VATS) Lobectomy or Wedge Resections - a Pilot Randomized Control Trial

McMaster University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年12月6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
20
试验地点
1
主要终点
Feasibility comparing two regional techniques in VATS surgery which is defined as the number of patients recruited per week.

研究概览

简要总结

This study will compare ESP block plus patient-controlled analgesia (PCA) to intercostal nerve block plus PCA as post-operative pain control for patients having video-assisted thorascopic surgeries.

详细描述

Video assisted thoracoscopic surgery (VATS) has become an increasingly popular technique in thoracic surgery with improvement in technology. It provides significant advantages over open thoracotomy procedures including reduced acute pain, reduced mortality, improved post-operative pulmonary function, and shorter hospitalization stays. Nevertheless, there is still considerable amount of post-operative acute pain with VATS lobectomies. Controlling post-operative pain is crucial because increased acute pain has been associated with the development of chronic pain.

Many patients receive either thoracic epidural (TEA) or paravertebral blocks (PVB) to treat post-operative pain in thoracotomy procedures as these techniques remain the gold standard. In contrast to thoracotomy procedures, it is unclear which is the best approach to analgesia is in VATS. A few studies have found no benefit in pain scores, patient satisfaction, pulmonary function, and incidence of side effects when comparing TEA with opioid patient controlled analgesia in VATS. Other studies have found minimal benefit in pain scores with TEA. The PVB has been used as alternative to TEA. One prospective observational study using PVB and continuous intercostal catheter demonstrated lower pain scores in VATS lobectomy. A randomized control trial (RCT) comparing PVB with wound infiltration in VATS lobectomy showed lower pain scores, lower morphine consumption, and higher patient satisfaction. However, both TEA and PVB have potential serious side-effects and complications. Complications of TEA include severe hypotension, epidural abscess, epidural hematomas and spinal cord injury. PVB have less incidence of hypotension but may involve risks like pneumothorax, pleural and vascular puncture, and higher systemic absorption of local anesthetics. PVB is also technically challenging and its spread is not reliable likely due to the presence of the endothoracic fasica. In addition, placement of both TEA and PVB require appropriate discontinuation of anticoagulants. Intercostal nerve blocks have been used as an analgesic alternative to TEA and PVB. One RCT found patients who had received intercostal blocks undergoing bilateral VATS for hyperhidrosis had lower pain scores in the post-anesthesia recovery unit (PACU). A combined retrospective and prospective study examined the analgesic effect and duration of intercostal blocks in patients undergoing VATS. The authors found that intercostal blocks decreased morphine consumption in the first 24 hours and the analgesic effect of the block lasted approximately 16 hours. Intercostal blocks appear to have some analgesic effect in the immediate post-operative period but are short-lived unless a catheter is placed. The standard practice for post-operative pain management for VATS lobectomy at St. Joseph's hospital consists of intercostal blocks performed by the thoracic surgeons at the end of surgery in combination with patient-controlled analgesia (PCA).

A novel regional technique called the Erector Spinae Plane (ESP) block has been recently described. This interfascial block involves ultrasound guided injection of local anesthetics posterior to the erector spinae muscle and superficial to transverse process of thoracic vertebrae at appropriate level. The ESP block appears to target the dorsal and ventral rami of the spinal nerves as they leave the intervertebral foramen. Cadaveric examination of ESP block showed extensive cranial-caudal spread of the block, approximately four dermatomes above and below the site of injection. The ESP block has been successfully applied in multiple clinical settings. For example, several patients suffering from chronic thoracic neuropathic pain achieved significant analgesia after receiving ESP blocks. ESP blocks have also been used as a rescue analgesia for a patient who failed a TEA after thoracotomy. Other applications include ventral hernia repair in abdominal surgery. The simplicity and safety of the ESP block has been proposed as its main advantages. Because it is a superficial interfascial plane block, it is distant from both the spinal cord and pleura. The ESP block is technically an easy to perform under ultrasound guidance due to its superficial location. There is also theoretically less possibility of needle related complications as the transverse process acts as a backstop for needle advancement. A catheter can be placed easily during the ESP block allowing continuous infusion and prolonged analgesia.

Given the importance of providing adequate analgesia in VATS lobectomy and wedge resections and lack of consensus amongst surgeons and anesthesiologists for the optimal analgesic technique, the investigators are proposing a prospective observational study to examine the analgesic efficacy of the ESP block in VATS lobectomy or wedge resections as a potential alternative to TEA, PVB and intercostal blocks. The investigators are hoping the results of this study will provide framework for future larger comparative studies.

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
None

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

  • •Elective video-assisted thoracoscopic surgeries (VATS) lobectomies
  • •Elective video-assisted thoracoscopic surgeries (VATS) wedge resections

排除标准

  • •Patient refusal
  • •Contraindications to regional anesthesia
  • •Known allergy to local anesthetics
  • •Bleeding diathesis
  • •Use of any anti-coagulants
  • •Inability to provide informed consent
  • •Severe kidney or liver disease
  • •Inability to operate PCA system

研究组 & 干预措施

ESP for VATS

Experimental

Erector Spinae plane (ESP) block

干预措施: Ultrasound guided erector spinae plane block (Procedure)

ICB for VATS

Active Comparator

Intercostal block (ICB)

干预措施: Intercostal block (Procedure)

结局指标

主要结局

Feasibility comparing two regional techniques in VATS surgery which is defined as the number of patients recruited per week.

时间窗: One week

Number of patients recruited per week

Number of adverse events (AEs) which can be attributed to the ESP block which is defines as the number of AEs occuring per week.

时间窗: One week

Number of adverse events

次要结局

  • Pain scores at rest and on movement(Two days post-operatively)
  • Dermatome distribution to test loss of sensation to pinpricks(Two days post-operatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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