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Oral Pregabalin Effect to the Intravenous Morphine in Multiple Fracture Ribs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03473093
Recruitment Status : Not yet recruiting
First Posted : March 22, 2018
Last Update Posted : March 23, 2018
Information provided by (Responsible Party):
Mina Medhat Mahfouz Eshak, Assiut University

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

Condition or disease Intervention/treatment Phase
Fracture; Rib, Multiple Drug: Pregabalin 150mg Drug: Morphine Early Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Adding Pregabalin to the Analgesic Effect of Intravenous Morphine in Patients With Multiple Fracture Ribs
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: morphine
This group will receive only morphine infusion (20microgram/kg/h)
Drug: Morphine
One group will receive morphine infusion 20 microgram/kg/h

Active Comparator: pregabalin
This group will receive only morphine infusion (20microgram/kg/h) and oral pregabalin (150 mg)
Drug: Pregabalin 150mg
One group will receive oral pregabalin with morphine infusion

Drug: Morphine
One group will receive morphine infusion 20 microgram/kg/h

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. I.C.U stay time [ Time Frame: one week ]
    decrease time

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03473093

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Contact: khaled mohamad morsy, PhD 01090477966

Sponsors and Collaborators
Assiut University

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Responsible Party: Mina Medhat Mahfouz Eshak, principal investigator, Assiut University Identifier: NCT03473093     History of Changes
Other Study ID Numbers: pain in multiple fracture ribs
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fractures, Bone
Rib Fractures
Fractures, Multiple
Wounds and Injuries
Thoracic Injuries
Multiple Trauma
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs