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