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临床试验/NCT04531553
NCT04531553已完成不适用

The Impact of Ultrasound-Guided Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in the Management of Acute and Chronic Post-Thoracotomy Pain: A Randomized, Controlled Study

National Cancer Institute, Egypt2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
2
主要终点
Pain intensity score

研究概览

简要总结

The thoracic epidural block (TEB) and thoracic paravertebral block (TPVB) are the most commonly used techniques for analgesia after thoracic surgery.Recently, erector spinae plane block (ESPB) was reported as a treatment for thoracic neuropathic pain.Dexmedetomidine has been primarily used for intra- venous sedation in intensive care settings. The unique analgesic properties of dexmedetomidine have encouraged the anesthesiologists to use it perineurally.

This study aims to evaluate the effect ultrasound erector spinae plane block with dexmedetomidine infusion in management of acute and chronic post thoracotomy pain.

详细描述

The thoracic epidural block (TEB) and thoracic paravertebral block (TPVB) are the most commonly used techniques for analgesia after thoracic surgery. However, TEA has several adverse effects, such as hypotension, motor blockade, hematoma, and abscess and TPVB has a chance of epidural spread and pneumothorax, and multiple injections are needed if more than 4 dermatome analgesia is required. Recently, erector spinae plane block (ESPB) was reported as a treatment for thoracic neuropathic pain.

ESPB is a relatively simple technique with easily identified sonographic landmarks, and a catheter is easily inserted into the plane after distention induced by the injection. Additionally, the ESPB has the potential to provide both somatic and visceral sensory blockade.

The selectivity of dexmedetomidine to the α2-receptors is eight times of its prototype, clonidine. Accordingly, dexmedetomidine is a more powerful sedative and analgesic drug than clonidine with less hemodynamic derangements from the α1-receptor activation. Dexmedetomidine has been primarily used for intra- venous sedation in intensive care settings. The unique analgesic properties of dexmedetomidine have encouraged the anesthesiologists to use it perineurally. Previous studies have declared that dexmedetomidine potentiates local anesthetic effect when administered by neuroaxial route.

This study aims to evaluate the effect ultrasound erector spinae plane block with dexmedetomidine infusion in management of acute and chronic post thoracotomy pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Physical status ASA I and II.
  • Age ≥ 18 and ≤ 65 Years.
  • Body mass index (BMI): > 20 kg/m2 and < 40 kg/m
  • Patient undergoing thoracotomy for cancer surgery (Lobectomy, Pneumonectomy, and Decortication).

排除标准

  • Patient refusal
  • Known sensitivity or contraindication to local anesthetics or dexmedetomidine.
  • History of psychological disorders.
  • Localized infection at the site of block.
  • Coagulopathies with platelet count below 50,000 or an INR>1.5.

结局指标

主要结局

Pain intensity score

时间窗: 1 week

measurement of Visual analogue score in a line 0 to 100 , where 0 indicates no pain and 100 indicates the worst pain.

次要结局

  • Number of patients who will develop post-thoracotomy pain syndrome.(3 months)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ehab Hanafy Shaker

Assistant professor of Anesthesia, intensive care and pain releif

National Cancer Institute, Egypt

研究点 (2)

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