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临床试验/NCT03860324
NCT03860324撤回不适用

Erector Spinae vs Fascia Iliaca Block in Hip Arthroplasty Post-operative Analgesia With Erector Spinae Plane Block After Total Hip Replacement Surgery

Hospital Beatriz Ângelo2 个研究点 分布在 1 个国家开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Post-operative pain level measured by morphine consumption using patient-controlled intravenous analgesia

研究概览

简要总结

The thoracic erector spinae plane (ESP) block was first described by Forero et al in September 2016. In their article, the authors presented the possibility of using this block as an option for the control of thoracic neuropathic pain as well as post-operative thoracic pain. The ESP block is done by administering local anesthetic in the plane deep to the erector spinae muscle, which spreads through the costotransverse foramen to the dorsal and ventral roots of the spinal nerves.

Since then, there have been reports about the successful use of this block for bariatric surgery, ventral hernia repair, radical mastectomy, rib fractures, major abdominal surgery and hip replacement. However, there are no studies in the literature comparing the efficacy of the ESP block to other nerve blocks.

The purpose of this study is to compare the post-operative analgesic efficacy of the ESP block to the fascia iliaca (FI) block after total hip replacement (THR).

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Surgical plan for total hip replacement
  • Signing of consent form to participate in the study

排除标准

  • Patient refusal
  • BMI > 40 kg/m2
  • Surgical plan for revision of hip replacement
  • Patient unable to quantify pain level
  • Chronic kidney disease with a Glomerular Filtration Rate < 50ml/min
  • Previously medicated with opioids
  • Patient unable to perform the surgery with spinal block
  • Allergy to local anesthetics
  • Infection in the site of the Erector Spinae Plane or Fascia Iliaca block
  • Allergy or contraindication to the use of morphine

结局指标

主要结局

Post-operative pain level measured by morphine consumption using patient-controlled intravenous analgesia

时间窗: At 24 hours post-operative

Total amount (in mg) of morphine administered by a patient-controlled intravenous analgesia pump of morphine 1mg/ml with bolus of 1ml per patient request with a lockout time of 10 minutes

Post-operative pain level measured by the Visual Analog Scale

时间窗: At 24 hours post-operative

Measurement of patient's pain level using the Visual Analog Scale (with a score of 0-100, 0 being no pain and 100 maximum pain)

次要结局

  • Sensory block assessed through a tactile stimulation test(At 24 hours post-operative)
  • Muscle Strength grade(At 24 hours post-operative)
  • Sensory block assessed through a temperature test(At 24 hours post-operative)
  • Detection of side effects related to the anesthetic and analgesic technique namely pruritus, urinary retention, nausea and vomiting in each patient(At 24 hours post-operative)

研究者

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

André Carrão

Principal Investigator

Hospital Beatriz Ângelo

研究点 (2)

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