- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03473093
Oral Pregabalin Effect to the Intravenous Morphine in Multiple Fracture Ribs
March 21, 2018 updated by: Mina Medhat Mahfouz Eshak, Assiut University
The Effect of Adding Pregabalin to the Analgesic Effect of Intravenous Morphine in Patients With Multiple Fracture Ribs
Determine the effect of using oral pregabalin on the analgesic effects of IV infusion of morphine in patients with multiple fracture ribs.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: khaled mohamad morsy, PhD
- Phone Number: 01090477966
- Email: khaledmorsy@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: morphine
This group will receive only morphine infusion (20microgram/kg/h)
|
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)
|
One group will receive morphine infusion 20 microgram/kg/h
One group will receive oral pregabalin with morphine infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
decrease pain
Time Frame: one week
|
measured by visual analogue score ranged from 0 to 10 with higher numbers are worse than lower numbers
|
one week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
I.C.U stay time
Time Frame: one week
|
decrease time
|
one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2018
Primary Completion (Anticipated)
March 1, 2019
Study Completion (Anticipated)
April 1, 2019
Study Registration Dates
First Submitted
March 8, 2018
First Submitted That Met QC Criteria
March 20, 2018
First Posted (Actual)
March 22, 2018
Study Record Updates
Last Update Posted (Actual)
March 23, 2018
Last Update Submitted That Met QC Criteria
March 21, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Multiple Trauma
- Fractures, Bone
- Fractures, Multiple
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pregabalin
- Morphine
Other Study ID Numbers
- pain in multiple fracture ribs
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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