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临床试验/NCT03473093
NCT03473093Unknown早期 1 期

The Effect of Adding Pregabalin to the Analgesic Effect of Intravenous Morphine in Patients With Multiple Fracture Ribs

Assiut University0 个研究点目标入组 80 人开始时间: 2018年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
80
主要终点
decrease pain

研究概览

简要总结

Determine the effect of using oral pregabalin on the analgesic effects of IV infusion of morphine in patients with multiple fracture ribs.

详细描述

Blunt chest trauma accounts for a significant proportion of debilitating and life-threatening injuries. Rib fractures are notoriously painful and can lead to prolonged hospitalization,contribute to the development of pneumonia and respiratory failure, and delay outpatient recovery significantly.Flail chest, along with chest wall deformity, the most severe of chest wall injuries, is associated with significant acute morbidity and mortality.Flail chest injury has been associated with a high mortality rates historically and up to 16 % more recently. In-patients with physiologic flail visibly apparent paradoxical chest wall motion leads to inefficient respiratory effort and compression of the lung and diminishes the negative intra thoracic pressure essential for the passive movement of air into the bronchial tree. Atelectasis leads to increased lung resistance and decreased compliance, making the work of breathing much more difficult. Loss of the ability to generate negative intra thoracic pressure with breathing also impairs venous return, a passive process dependent on the negative intra thoracic pressure generated with each breath. In patients without a visible flail segment, i.e., an anatomic or radiologic flail,the physiologic derangements can be similarly destructive.There is mounting evidence that a patient's perception of pain in the early post-injury period is associated with chronic pain development . A recent prospective study of rib fracture patients found that pain and disability at 8 weeks post injury could be predicted by the pain intensity within the first few days after injury . Interestingly, the number of fractures and the bilaterality of fractures were not predictive. Thus, pain management in the early post-injury setting is likely paramount to obtaining a more favorable recovery. Opioids, are traditional first-line therapy for acute rib fracture pain. But because of chronic misuse potential and central desensitization concerns, pain researchers and clinicians are increasingly recommending that opioids be used only in combination with other analgesic modalities such acetaminophen, nonsteroidal anti-inflammatory medication(NSAID), the anticonvulsants gabapentin and pregabalin,and the topical lidocaine patch

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients above 18 years old
  • ASA [1] and ASA [2]
  • mentally competent and able to give consent for enrollment in the study

排除标准

  • Patient coma scale less than 10
  • Impaired kidney functions
  • Chronic pain syndromes and patients with chronic opioid use

研究组 & 干预措施

morphine

Active Comparator

This group will receive only morphine infusion (20microgram/kg/h)

干预措施: Morphine (Drug)

pregabalin

Active Comparator

This group will receive only morphine infusion (20microgram/kg/h) and oral pregabalin (150 mg)

干预措施: Pregabalin 150mg (Drug)

pregabalin

Active Comparator

This group will receive only morphine infusion (20microgram/kg/h) and oral pregabalin (150 mg)

干预措施: Morphine (Drug)

结局指标

主要结局

decrease pain

时间窗: one week

measured by visual analogue score ranged from 0 to 10 with higher numbers are worse than lower numbers

次要结局

  • I.C.U stay time(one week)

研究者

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

Mina Medhat Mahfouz Eshak

principal investigator

Assiut University

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