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Oral Pregabalin Effect to the Intravenous Morphine in Multiple Fracture Ribs

Primary Purpose

Fracture; Rib, Multiple

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Pregabalin 150mg
Morphine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture; Rib, Multiple

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    morphine

    pregabalin

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    I.C.U stay time
    decrease time

    Full Information

    First Posted
    March 8, 2018
    Last Updated
    March 21, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03473093
    Brief Title
    Oral Pregabalin Effect to the Intravenous Morphine in Multiple Fracture Ribs
    Official Title
    The Effect of Adding Pregabalin to the Analgesic Effect of Intravenous Morphine in Patients With Multiple Fracture Ribs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2018 (Anticipated)
    Primary Completion Date
    March 2019 (Anticipated)
    Study Completion Date
    April 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

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

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fracture; Rib, Multiple

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    morphine
    Arm Type
    Active Comparator
    Arm Description
    This group will receive only morphine infusion (20microgram/kg/h)
    Arm Title
    pregabalin
    Arm Type
    Active Comparator
    Arm Description
    This group will receive only morphine infusion (20microgram/kg/h) and oral pregabalin (150 mg)
    Intervention Type
    Drug
    Intervention Name(s)
    Pregabalin 150mg
    Intervention Description
    One group will receive oral pregabalin with morphine infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine
    Intervention Description
    One group will receive morphine infusion 20 microgram/kg/h
    Primary Outcome Measure Information:
    Title
    decrease pain
    Description
    measured by visual analogue score ranged from 0 to 10 with higher numbers are worse than lower numbers
    Time Frame
    one week
    Secondary Outcome Measure Information:
    Title
    I.C.U stay time
    Description
    decrease time
    Time Frame
    one week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    khaled mohamad morsy, PhD
    Phone
    01090477966
    Email
    khaledmorsy@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22472394
    Citation
    Cannon RM, Smith JW, Franklin GA, Harbrecht BG, Miller FB, Richardson JD. Flail chest injury: are we making any progress? Am Surg. 2012 Apr;78(4):398-402.
    Results Reference
    background
    PubMed Identifier
    8722735
    Citation
    Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009.
    Results Reference
    background
    PubMed Identifier
    3785962
    Citation
    Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
    Results Reference
    background

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    Oral Pregabalin Effect to the Intravenous Morphine in Multiple Fracture Ribs

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