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临床试验/NCT03413059
NCT03413059Unknown2 期

Thoracic Epidural Morphine Versus Triamcinolone Acetonide Analgesia in Flail Chest

Assiut University0 个研究点目标入组 40 人开始时间: 2018年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
40
主要终点
visual analogue score

研究概览

简要总结

The applicability of different thoracic epidural analgesia for patients with flail chest

详细描述

Pain due to traumatic rib fractures may be associated with increased morbidity and mortality. Fracture ribs cause severe pain that adversely affects patients' ability to cough and breathe deeply, that may lead to decreased ventilator efforts, atelectasis, pneumonia and finally respiratory failure. That further results in longer intensive care unit (ICU) and hospital length of stay and higher mortality. Effective pain relief, chest physiotherapy and respiratory care are the points of management. Effective analgesia enables the patient to breathe deeply, cough out the secretions and comply with chest physiotherapy. Multiple pain relief treatment options are available, such as oral analgesics, intravenous opioids, patient-controlled opioid analgesia, interpleural blocks, intercostals blocks, para vertebral blocks, and epidural analgesia Recent studies reported that epidural analgesia reduces morbidity after major thoracic, abdominal and vascular surgeries, but in patients with rib fractures, Successful treatment for rib fracture pain usually requires both pharmacologic and interventional approaches .Single modality treatment, which may incite respiratory depression, is suboptimal in these patients, many of whom already manifest a compromised respiratory system. Interventional procedures, while opioid sparing, carry their own inherent risks. Intercostals nerve blocks may not be feasible in the setting of multiple rib fractures, because of patient discomfort and the risk of local aesthetic toxicity. Use of an epidural catheter with continuous infusion of local anaesthetics and opioids may pose challenges in a community hospital setting, as 24 hours in-house coverage is often unavailable. While single-shot thoracic epidural steroid injections have been used for herniated intervertebral discs, herpes zoster pain, and post herpetic neuralgia (PHN), their use in patients with rib fracture pain has not been previously reported in the literature. An epidural steroid injection delivers steroids directly into the epidural space in the spine. Sometimes additional fluid (local aesthetic and/or a normal saline solution) is used to help 'flush out' inflammatory mediators from around the area that may be a source of pain ..Typically, a solution containing cortisone (steroid) with local aesthetic (lidocaine or bupivacaine), and/or saline is used.A steroid, or cortisone, is usually injected as an anti-inflammatory agent. Inflammation is a common component of many low back conditions and reducing inflammation helps reduce pain. Triamcinolone acetonide, Dexamethasone, and Methyl prednisolone acetate are commonly used steroids.

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, Care Provider)

入排标准

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

入选标准

  • Older than 18 years.
  • American Society of Anesthesiologists physical status 1 or
  • mentally competent and able to give consent for enrollment in the study

排除标准

  • Patient refusal.
  • Psychiatric disorder
  • Patient younger than 18 years old
  • Allergy to local anesthetics, systemic opioids (fentanyl, morphine)
  • Impaired kidney functions and patient with coagulopathy will be also excluded.
  • Chronic pain syndromes and patients with chronic opioid use defined as use of regular daily doses of systemic narcotics for the past 6 months prior to the surgery.
  • BMI of 40 or more

研究组 & 干预措施

morphine sulfate group

Active Comparator

patients in this arm will receive : morphine dose 0.1mg /kg with 9 ml of 0.25 % bupivacaine with through epidural catheter on admission Then continuous epidural infusion of bupivacaine (0.1 mg.kg-1.h) 1st 72 hours

干预措施: Morphine Sulfate (Drug)

triamcinolone acetonide group

Active Comparator

patients in this arm will receive will receive a mixture of 9 ml of 0.125 % bupivacaine with 80mg of triamcinolone ( 10 ml total volume) through epidural catheter on admission

干预措施: Triamcinolone Acetonide (Drug)

结局指标

主要结局

visual analogue score

时间窗: 7 days

mean visual analogue score (scale of 0 to 100) indicating the severity of pain

次要结局

  • ICU stay(7 days)
  • chest infection(7 days)
  • hospital stay(7 days)

研究者

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

Mostafa hassanien hassanien bakr

assitent lecturer

Assiut University

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