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临床试验/NCT05507281
NCT05507281已完成不适用

Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Thoracotomy

Tanta University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Pain assessment

研究概览

简要总结

Comparing efficacy of Ultrasound-guided Erector Spinae Plane Block versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Thoracotomy

详细描述

Thoracotomy is one of the most painful surgical procedures. The reported incidence of persistent pain after thoracic surgery (post thoracotomy pain syndrome) has been reported in 20%-70% of patients. Inadequately treated post thoracotomy pain can have several negative consequences. Therefore, pain relief is essential to facilitate coughing and deep breathing and to promote early mobilization.

Thoracic epidural analgesia and thoracic paravertebral block are strongly recommended techniques for managing post thoracotomy pain to reduce opioid use and the related adverse effects as hypoventilation, depression of cough reflex, nausea and vomiting. However, they can be technically challenging to perform and are associated with up to 15% failure rate in Thoracic epidural analgesia and potential risk of pneumothorax in thoracic paravertebral block.

Erector spinae plane block is a relatively novel ultrasound-guided regional technique. Its application in patients with chronic thoracic neuropathic pain and acute surgical pain has been described by Forero et al.

Retrolaminar block is an easy and safe analgesic technique. It has been reported to be satisfactory for post-operative analgesia after breast surgery.

To our knowledge there is no clinical studies, comparing the effectiveness of both blocks on postthoracotomy pain, has been reported.

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)

盲法说明

An anesthesiologist gave the block and outcomes were obtained by another one blinded to the study group. PHILIPS ultrasound machine and high frequency linear array probe with a frequency of 5-13 MHZ will be used.

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 21-65 years old of both sexes.
  • Patients were scheduled for elective thoracotomy.
  • Their ASA physical status classification is II-III.

排除标准

  • Patients' refusal.
  • Local infection at the site of block.
  • Coagulation abnormalities.
  • Sever spinal deformity e.g. scoliosis.
  • Known hypersensitivity to local anesthetics.
  • Mental dysfunction and cognitive disorders.
  • History of drug abuse and chronic analgesic use.

结局指标

主要结局

Pain assessment

时间窗: 24 hours postoperatively.

The Numeric Pain Rating Scale is a valid and simple approach to pain assessment (0= no pain and 10= worst possible pain). Postoperative pain will be assessed at emergence and 2nd, 4th, 8th, 12th, 18th and 24th hour postoperatively.

次要结局

  • The time of first analgesic request(24 hours postoperatively)
  • The total amount of morphine(24 hours postoperatively)

研究者

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

Fatma Adel Momen Elshazly

Principal Investigator

Tanta University

研究点 (2)

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