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Clinical Trials/NCT03473093
NCT03473093
Unknown
Early Phase 1

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

Assiut University0 sites80 target enrollmentMarch 2018

Overview

Phase
Early Phase 1
Intervention
Morphine
Conditions
Fracture; Rib, Multiple
Sponsor
Assiut University
Enrollment
80
Primary Endpoint
decrease pain
Last Updated
8 years ago

Overview

Brief Summary

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

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
March 2018
End Date
April 2019
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mina Medhat Mahfouz Eshak

principal investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

morphine

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

Intervention: Morphine

pregabalin

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

Intervention: Pregabalin 150mg

pregabalin

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

Intervention: Morphine

Outcomes

Primary Outcomes

decrease pain

Time Frame: one week

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

Secondary Outcomes

  • I.C.U stay time(one week)

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