Fracture; Rib, MultipleEarly Phase 1NCT03473093
Oral Pregabalin Effect to the Intravenous Morphine in Multiple Fracture Ribs
A Early Phase 1 study testing Pregabalin 150mg and Morphine in people with Fracture; Rib, Multiple, run by Assiut University.
Trial summary
Determine the effect of using oral pregabalin on the analgesic effects of IV infusion of morphine in patients with multiple fracture ribs. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Fracture; Rib, Multiple
- What is being tested?
- Pregabalin 150mg and Morphine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Apr 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients above 18 years old
- ASA [1] and ASA [2]
- mentally competent and able to give consent for enrollment in the study
Who cannot join
- Patient coma scale less than 10
- Impaired kidney functions
- Chronic pain syndromes and patients with chronic opioid use
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Conditions
- Fracture; Rib, Multiple
- Being tested
- Pregabalin 150mg, Morphine
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 150mgDrug
One group will receive oral pregabalin with morphine infusion
MorphineDrug
One group will receive morphine infusion 20 microgram/kg/h
| Study group | Role | What they receive |
|---|---|---|
| morphine | Active comparator | This group will receive only morphine infusion (20microgram/kg/h) Receives: Drug: Morphine |
| pregabalin | Active comparator | This group will receive only morphine infusion (20microgram/kg/h) and oral pregabalin (150 mg) Receives: Drug: Pregabalin 150mg; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease pain
measured by visual analogue score ranged from 0 to 10 with higher numbers are worse than lower numbers
Measured: one week
Secondary outcomes (1)
I.C.U stay time
decrease time
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study startMar 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fracture; Rib, MultipleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Medhat Mahfouz Eshak, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473093
- Sponsor's protocol ID
- pain in multiple fracture ribs
- Status last verified
- Mar 2018
- First submitted
- 8 Mar 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22472394Katz 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.
PubMed 8722735Jensen 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.
PubMed 3785962
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Pregabalin to the Analgesic Effect of Intravenous Morphine in Patients With Multiple Fracture Ribs
- ClinicalTrials.gov ID
- NCT03473093
- Acronym / sponsor ID
- pain in multiple fracture ribs
- Conditions
- Fracture; Rib, Multiple
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morphine | Active comparator | Drug: MorphineThis group will receive only morphine infusion (20microgram/kg/h) |
| pregabalin | Active comparator | Drug: Pregabalin 150mg, Drug: MorphineThis group will receive only morphine infusion (20microgram/kg/h) and oral pregabalin (150 mg) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients above 18 years old
- ASA [1] and ASA [2]
- mentally competent and able to give consent for enrollment in the study
Key exclusion criteria (3 listed)
- Patient coma scale less than 10
- Impaired kidney functions
- Chronic pain syndromes and patients with chronic opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregabalin 150mgOne group will receive oral pregabalin with morphine infusion | Drug | pregabalin |
| MorphineOne group will receive morphine infusion 20 microgram/kg/h | Drug | morphine, pregabalin |
Primary outcome
decrease pain
Time frame: one week
measured by visual analogue score ranged from 0 to 10 with higher numbers are worse than lower numbers
1 secondary outcome
I.C.U stay time
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
- Background: PubMed 22472394Cannon 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.
- Background: PubMed 8722735Katz 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.
- Background: PubMed 3785962Jensen 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.
Related trials for Fracture; Rib, Multiple
RecruitingPhase 4
INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Rib Fractures
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
Recruiting
Parascapular Sub Iliocostalis Plane Block Versus Thoracic Paravertebral Plane Block for Traumatic Multiple Rib Fractures
Discitis of Thoracic Region
Enrolling by invitation
Ultrasound-Guided Percutaneous Cryoneurolysis to Treat Pain Following Thoracic Trauma
Rib Fracture, Rib Fracture Multiple
RecruitingObservational study
Assessment of Morbidity and Mortality Following Serratus Anterior Plane Block (SAPB) for Unilateral Rib Fractures
Pain Management, Rib Fracture Multiple
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pregabalin 150mg and Morphine in people with Fracture; Rib, Multiple, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact khaled mohamad morsy, PhD (01090477966, khaledmorsy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decrease pain (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03473093, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2018.