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临床试验/NCT04486014
NCT04486014Unknown不适用

A Comparative Study of the Analgesic Effect of Ultrasound-guided Erector Spinae Plane Block Versus Serratus Anterior Plane Block for Thoracoscopic Sympathectomy Surgeries

Mansoura University2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年9月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
110
试验地点
2
主要终点
The total analgesic consumption

研究概览

简要总结

  • Thoracic incisions are painful and associated with chronic post-surgical pain and inadequate analgesia is associated with poorer postoperative outcomes. Recent progress has been made in the field of thoracic anesthesia by improving analgesic modalities such as PECS 1 and PECS 2, intercostal plane block, paravertebral regional anesthesia, ultrasound-guided erector spinae and serratus anterior plane block.
  • Administered of the local anesthetic in erector spinae plane block is in the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces. It affects both the ventral and dorsal rami and leading to blockage of both visceral and somatic pain.
  • Ultrasound-guided serratus anterior plane block is a facial plane block that provides analgesia by blocking of lateral branches of intercostal nerves above or below the serratus plane muscle.
  • We hypothesize that the ultrasound-guided erector spinae plane block may have better quality than the serratus anterior plane block for patients undergoing thoracoscopic sympathectomy as erector spinea plane blocks visceral and somatic pain.

详细描述

Primary palmar hyperhidrosis (PPH) refers to the excessive secretion of exocrine glands on the palms, which is often accompanied by the head, face, or plantar hyperhidrosis. PPH demonstrates no obvious organic cause; however, some patients may feel distressed because their palms sweat more than normal, and such a situation may lead to severe psychological, social, and occupational dysfunction.

Endoscopic thoracic sympathectomy abolishes eccrine sweating in all areas supplied by the postganglionic fibers with its complications which include post-sympathetic neuralgia which is the most important, wound infection, hemorrhage, pneumothorax, horner syndrome, no response to the operation and compensatory hyperhidrosis in non-denervated areas.

Forero described ultrasound-guided erector spinae plane block for treatment of thoracic neuropathic pain and explained it as a peri-paravertebral regional anesthesia technique that has been used for prevention of postoperative pain in various surgeries.

Ultrasound-guided serratus anterior plane block is a facial plane block which provides analgesia by blocking of lateral branches of intercostal nerves above or below the serratus plane muscle. There are few cases and studies in the literature reporting successful analgesia provided by serratus anterior plane block

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Single-blind (participant) study

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists grade I or II physical status

排除标准

  • Patients who had coagulopathies
  • local infections
  • neuropathies
  • neuromuscular disease
  • psychiatric disease
  • history of thoracic surgery
  • history of allergy to local anesthetics.
  • receiving chronic analgesic therapy
  • drug abusers

结局指标

主要结局

The total analgesic consumption

时间窗: 1st 24 hours after surgery

cumulative consumption of opioids during the first postoperative day

次要结局

  • The total amount of fentanyl consumption(1st 24 hours after surgery)
  • Duration of analgesia(within 24 hours after surgery)
  • Nausea(1st 24 hours after surgery)
  • mean blood pressures(Intraoperative (every 10 minutes till the end of surgery))
  • Vomiting(1st 24 hours after surgery)
  • systolic blood pressure(Intraoperative (every 10 minutes till the end of surgery))
  • diastolic blood pressures(Intraoperative (every 10 minutes till the end of surgery))
  • Postoperative severity of the pain(every 2 hours for 12hours and then at 16, 20 and 24 hours postoperatively)
  • The total amount of paracetamol consumption(1st 24 hours after surgery)
  • Peripheral oxygen saturation(Intraoperative (every 10 minutes till the end of surgery))
  • Patient Satisfaction(After 12 and 24 hours after surgery)
  • Heart rate(Intraoperative (every 10 minutes till the end of surgery))
  • End-tidal carbon dioxide tension(Intraoperative (every 10 minutes till the end of surgery))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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