Rib FracturesPhase 3NCT04928300
Low Dose Dexmedetomidine Versus Normal Saline in Multiple Fracture Ribs
A Phase 3 study testing Dexmedetomidine and 0.9% saline in people with Rib Fractures, run by Assiut University at 1 site in Egypt.
Trial summary
In our study, we assess the diaphragmatic function, pain quality and anti-inflammatory properties between low dose infusion of dexmedetomidine normal saline in patients with multiple fracture ribs on conservative treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rib Fractures
- What is being tested?
- Dexmedetomidine and 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jun 2021to 25 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age 18-65 years) of American Society of Anaesthesiologists (ASA) physical status I-II
- Traumatic multiple fracture ribs 3 ribs or more, who will be subjected to thorough assessments including chest 3D-CT
- Undergoing conservative treatment (chest strappings)
- Intractable pain with visual analogue scale (VAS) over 6 after traditional therapies
- Glasgow Coma Scale (GCS) ≥ 13.
Who cannot join
- Multiple traumas to body parts other than chest with an abbreviated injury scale over 3
- Serious head trauma with a Glasgow coma scale lower than 13
- Mechanically ventilated patients
- Massive hemothorax
- Injury to the trachea or bronchus with requirement for immediate surgery
- Dementia
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- Use of corticosteroids during ICU stay
- Sepsis
- Continued use of neuromuscular blocking agents and aminoglycosides antibiotic use as they are known risk factors for ICU-acquired weakness and any known hypersensitivity
- Contraindication to the study drugs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university hospital
Asyut, Assuit, Assuit universi
Omar Soliman, 01101266040, omarmakram347@yahoo.com
About this study
Official title: Diaphragmatic Function, Pain Quality & Anti-inflammatory Properties: A Low Dose Dexmedetomidine Versus Ketamine in Patients With Multiple Fracture Ribs Needing Conservative Treatment
In our study, we assess the diaphragmatic function, pain quality and anti-inflammatory properties between low dose infusion of dexmedetomidine normal saline in patients with multiple fracture ribs on conservative treatment.
Read the detailed description
A written informed consent from patients or thier legal guardians, Patients will be assigned randomly to two groups (30 subjects each) with traumatic multiple fracture ribs 3 ribs or more. After thoracic epidural is inserted, the drug study intervention will be started and run for 5 days during ICU admission. In (Group D) low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days. In (Group C) the same dose and duration of normal saline will be given.
- Conditions
- Rib Fractures
- Being tested
- Dexmedetomidine, 0.9% saline
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days.
0.9% salineOther
Also called Normal saline
the same dose and duration of normal saline will be given for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Group D | Experimental | Dexmedetomidine infusion IV for 5 days. Receives: Drug: Dexmedetomidine |
| Group C | Placebo comparator | The same dose and duration of normal saline will be given. Receives: Other: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic diaphragm function
Diaphragmatic excursion and thickness will be assessed by ultasound for 5 days with diaphragmatic dysfunction (DD) is diagnosed if diaphragmatic excursion is <10 mm and diaphragmatic thickness is <2 mm. .
Measured: 5 days
Secondary outcomes (1)
Visual analogue scale for pain
Severity of pain will be assessed and scored by 10-point visual analogue scale (VAS). The patients will be instructed on how to use VAS for the assessment of the degree of pain (with 0 representing no pain and 10 cm representing the worst imaginable pain). According to the degree pain given by the patient, classification of pain severity will be done as follows: no pain = 0, mild pain <3, moderate pain 4-6 and severe pain >7. VAS will be recorded at zero time before drug intervention, 4 h, 6 h, 12 h, 24 h and 48 h after the start of the treatment in all groups by the anesthesia resident not involved in any other part of the study.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start12 Jun 2021
- Primary completion1 Jul 2027 (estimated)
- Study completion25 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rib FracturesStudies 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Makram Soliman, Assiut University
- Investigators
- Omar Soliman, MD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928300
- Sponsor's protocol ID
- 17300614
- Status last verified
- Dec 2025
- First submitted
- 10 Jun 2021
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bossolasco M, Bernardi E, Fenoglio LM. Continuous serratus plane block in a patient with multiple rib fractures. J Clin Anesth. 2017 May;38:85-86. doi: 10.1016/j.jclinane.2016.12.015. Epub 2017 Jan 30. No abstract available.
PubMed 28372691
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Function, Pain Quality & Anti-inflammatory Properties: A Low Dose Dexmedetomidine Versus Ketamine in Patients With Multiple Fracture Ribs Needing Conservative Treatment
- ClinicalTrials.gov ID
- NCT04928300
- Acronym / sponsor ID
- 17300614
- Conditions
- Rib Fractures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 12 Jun 2021 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 25 Jul 2027 (estimated)
- First posted
- 16 Jun 2021 (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.
In our study, we assess the diaphragmatic function, pain quality and anti-inflammatory properties between low dose infusion of dexmedetomidine normal saline in patients with multiple fracture ribs on conservative treatment.
Detailed description
A written informed consent from patients or thier legal guardians, Patients will be assigned randomly to two groups (30 subjects each) with traumatic multiple fracture ribs 3 ribs or more. After thoracic epidural is inserted, the drug study intervention will be started and run for 5 days during ICU admission. In (Group D) low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days. In (Group C) the same dose and duration of normal saline will be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Experimental | Drug: DexmedetomidineDexmedetomidine infusion IV for 5 days. |
| Group C | Placebo comparator | Other: 0.9% salineThe same dose and duration of normal saline will be given. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (age 18-65 years) of American Society of Anaesthesiologists (ASA) physical status I-II
- Traumatic multiple fracture ribs 3 ribs or more, who will be subjected to thorough assessments including chest 3D-CT
- Undergoing conservative treatment (chest strappings)
- Intractable pain with visual analogue scale (VAS) over 6 after traditional therapies
- Glasgow Coma Scale (GCS) ≥ 13.
Key exclusion criteria (10 listed)
- Multiple traumas to body parts other than chest with an abbreviated injury scale over 3
- Serious head trauma with a Glasgow coma scale lower than 13
- Mechanically ventilated patients
- Massive hemothorax
- Injury to the trachea or bronchus with requirement for immediate surgery
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 |
|---|---|---|
| DexmedetomidineAlso: Precedexlow dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days. | Drug | Group D |
| 0.9% salineAlso: Normal salinethe same dose and duration of normal saline will be given for 5 days. | Other | Group C |
Primary outcome
Ultrasonographic diaphragm function
Time frame: 5 days
Diaphragmatic excursion and thickness will be assessed by ultasound for 5 days with diaphragmatic dysfunction (DD) is diagnosed if diaphragmatic excursion is <10 mm and diaphragmatic thickness is <2 mm. .
1 secondary outcome
Visual analogue scale for pain
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Results publication: PubMed 28372691Bossolasco M, Bernardi E, Fenoglio LM. Continuous serratus plane block in a patient with multiple rib fractures. J Clin Anesth. 2017 May;38:85-86. doi: 10.1016/j.jclinane.2016.12.015. Epub 2017 Jan 30. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Rib Fractures
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INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
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Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
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Effectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes
Rib Fractures, Blunt Chest Trauma
Not yet recruitingPhase 2/3
Comparison of Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Erector Spinae Plane Block for Acute Pain Management in Patients With Traumatic Rib Fractures
Rib Fractures, Acute Pain
RecruitingObservational study
GNRI and PNI for Predicting Short-Term Outcomes in Older Adults With Multiple Rib Fractures
Multiple Rib Fractures, Isolated Blunt Thoracic Trauma
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.
Omar Soliman, MD study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and 0.9% saline in people with Rib Fractures, run by Assiut University at 1 site in Egypt.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Soliman, MD (01101266040, omarmakram347@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic diaphragm function (time frame: 5 days). 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 NCT04928300, which also lists 1 linked publication.
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 2 Jan 2026.