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临床试验/NCT04719507
NCT04719507Unknown不适用

Ultrasound Guided Erector Spinae Block Versus Thoracic Paravertebral Block for Postoperative Pain Control After Open Nephrectomy : A Randomized Controlled Trial

Cairo University0 个研究点目标入组 45 人开始时间: 2021年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
45
主要终点
Total morphine requirements 24 hours postoperatively

研究概览

简要总结

the study aims to compare the analgesic efficacy of erector spinae plane block versus thoracic paravertebral block after open nephrectomy surgery.

详细描述

Open nephrectomy is associated with substantial postoperative pain, pain relief in patients undergoing this procedure is usually provided either by thoracic epidural analgesia (EA) or systemic analgesics. EA is a very useful option for the management of postoperative pain in patients undergoing abdominal surgeries, but the risks and contraindications linked to EA like hypotension ,headache ,nerve damage or infection may limit its use. Systemic analgesics in the form of opioid analgesics may give rise to side effects like nausea ,vomiting ,constipation, allergy or drowsiness and often provide insufficient analgesia. Hence, other methods of postoperative pain management are desired. Sensory level target according to the incision site Flank(T9-T11) , Thoraco-abdominal (T7-T12 ) and Trans-abdominal (T6-T10).

Ultrasound (US) guided erector spinae plane (ESP) block is one of the interfascial plane blocks that target the dorsal and ventral rami of the spinal nerves. Although there is no sufficient evidence for the spread of local anesthetic to the ventral rami, recent anecdotal reports demonstrated effective postoperative analgesia after thoracic and lumbar surgeries affecting both the ventral and dorsal rami .According to a previous study, Erector Spinae Plane block has allowed a reduction in opioid consumption and excellent pain control in partial nephrectomy.

Paravertebral block (PVB) is a technique where a local anesthetic is deposited into a space found on both sides of the spine, called the paravertebral space. It is a block with a dermatomal distribution of pain relief depending on the level of the spine at which the block is sited and the quantity and type of deposited local anesthetic.

PVB is effective for pain relief in the thoracic, abdominal and limb regions .

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
Double (Participant, Care Provider)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (30-60 years) .
  • Patients with ASA I , II score

排除标准

  • Patient's refusal
  • Coagulopathy to be cancelled if ( INR>1.4 , Platelets count <100x109 )
  • Infection at the injection site.
  • Allergy to local anesthetics.
  • Patients receiving opioids for chronic analgesic therapy

研究组 & 干预措施

erector spinae arm

Experimental

ultrasound guided erector spinae block

干预措施: erector spinae block (Procedure)

thoracic paravertebral arm

Experimental

ultrasound guided thoracic paravertebral block.

干预措施: thoracic paravertebral block (Procedure)

drug arm

Active Comparator

pethidine (1 mg/kg ) once

干预措施: Pethidine Only Product in Parenteral Dose Form (Drug)

结局指标

主要结局

Total morphine requirements 24 hours postoperatively

时间窗: 24 hours postoperative

morphine increment ( 0.02 mg/kg IV ) will be added to maintain a resting visual analogue score at \<3 and the total 24-hours morphine consumption will be recorded

次要结局

  • Time span to the first postoperative analgesia(calculated from the time of intervention till the time of the first rescue dose of morphine,expected form 2-3 hours)
  • Visual analogue score at 2, 4, 6, 12, 18, and 24 hours postoperatively(2, 4, 6, 12, 18, and 24 hours postoperatively)
  • operation time(from start of anesthesia till the end of surgery , expected from 3-4 hours)

研究者

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

Ezzat Ramzy Ezz

principle investigator

Cairo University

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