Rib FracturesPhase 2/3NCT07827157
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
A Phase 2/3 study testing Dexmedetomidine with Bupivacaine in ESPB and Dexamethasone with Bupivacaine in ESPB in people with Rib Fractures and Acute Pain, run by Assiut University.
Trial summary
Traumatic rib fractures cause severe chest wall pain that can impair normal breathing, coughing, and lung function. While systemic opioids are commonly used to treat traumatic pain, their side effects, such as sedation and respiratory depression, can complicate recovery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rib Fractures, Acute Pain, Thoracic Trauma
- What is being tested?
- Dexmedetomidine with Bupivacaine in ESPB and Dexamethasone with Bupivacaine in ESPB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Phase 2/3
- 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
- Adult patients aged 18 to 65 years
- Both sexes
- American Society of Anesthesiologists (ASA) physical status I-II
- Acute traumatic rib fractures confirmed by appropriate imaging
- Flail-chest patients who are hemodynamically and respiratory stable to undergo erector spinae plane block (ESPB) and reliable assessment
- Spontaneously breathing patients or patients receiving supplemental oxygen/non-invasive respiratory support without an immediate indication for intubation
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- Ability to report pain using a Numeric Rating Scale (NRS)
- Presentation within 24 hours of trauma
- Ability to provide written informed consent
Who cannot join
- Patient refusal to participate
- Immediate need for endotracheal intubation or invasive mechanical ventilation prior to randomization or block placement
- Hemodynamic instability requiring immediate resuscitation or vasopressor support precluding safe regional anesthesia
- Cardiorespiratory arrest or peri-arrest status
- Severe associated traumatic brain injury or other injuries preventing reliable clinical evaluation
- Major associated injury requiring immediate emergency operative or interventional procedures that prevent protocol completion
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- Coagulopathy or any contraindication to regional anesthesia
- Local infection at the anticipated block needle insertion site
- Known allergy to amide local anesthetics, dexmedetomidine, or dexamethasone
- Significant bradyarrhythmia, high-grade atrioventricular block, or contraindication to dexmedetomidine
- Chronic opioid consumption or chronic pain syndromes requiring regular analgesic therapy
- Prior regional anesthesia performed for the current trauma
- Inability to cooperate with the procedure or pain evaluation
About this study
Official title: 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: A Prospective Randomized Double-Blind Controlled Study
Traumatic rib fractures cause severe chest wall pain that can impair normal breathing, coughing, and lung function. While systemic opioids are commonly used to treat traumatic pain, their side effects, such as sedation and respiratory depression, can complicate recovery. Regional nerve blocks like the ultrasound-guided erector spinae plane block (ESPB) offer targeted pain relief while minimizing opioid requirements.
The purpose of this clinical trial is to compare the analgesic efficacy and respiratory outcomes of adding dexmedetomidine versus dexamethasone to bupivacaine during an ultrasound-guided ESPB in emergency department patients with acute traumatic rib fractures.
Read more
Participants aged 18 to 65 years presenting within 24 hours of rib injury will be randomly assigned to one of two groups:
- Dexmedetomidine Group: Receives an ultrasound-guided ESPB with bupivacaine plus dexmedetomidine.
- Dexamethasone Group: Receives an ultrasound-guided ESPB with bupivacaine plus dexamethasone.
The primary outcome is the duration of analgesia, measured as the time to the first request for rescue pain medication. Secondary outcomes include pain scores at rest and during coughing/deep breathing, total 24-hour opioid consumption, diaphragmatic motion evaluated by ultrasound, respiratory recovery, and the incidence of adverse events over a 24-hour follow-up period.
- Conditions
- Rib Fractures, Acute Pain, Thoracic Trauma
- Being tested
- Dexmedetomidine with Bupivacaine in ESPB, Dexamethasone with Bupivacaine in ESPB
- Keywords
- Erector spinae plane block, ESPB, Dexmedetomidine, Dexamethasone, Bupivacaine, Ultrasound-guided regional anesthesia, Rib fracture analgesia, Diaphragmatic excursion
- Medical subject headings
- Rib Fractures, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine with Bupivacaine in ESPBDrug
Ultrasound-guided thoracic erector spinae plane block (ESPB) administered deep to the erector spinae muscle and superficial to the transverse process (typically T4-T6) using bupivacaine supplemented with dexmedetomidine (0.5 mcg/kg) following local skin infiltration with 5 mL of 2% lidocaine.
Dexamethasone with Bupivacaine in ESPBDrug
Ultrasound-guided thoracic erector spinae plane block (ESPB) administered deep to the erector spinae muscle and superficial to the transverse process (typically T4-T6) using bupivacaine supplemented with dexamethasone (4 mg) following local skin infiltration with 5 mL of 2% lidocaine.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Active comparator | Participants receive an ultrasound-guided erector spinae plane block (ESPB) with bupivacaine plus dexmedetomidine (0.5 mcg/kg) following local skin infiltration with 5 mL of 2% lidocaine. Receives: Drug: Dexmedetomidine with Bupivacaine in ESPB |
| Dexamethasone Group | Active comparator | Participants receive an ultrasound-guided erector spinae plane block (ESPB) with bupivacaine plus dexamethasone (4 mg) following local skin infiltration with 5 mL of 2% lidocaine. Receives: Drug: Dexamethasone with Bupivacaine in ESPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Rescue Analgesic Request
Time (in minutes) from the completion of the ultrasound-guided erector spinae plane block until the patient's first request for rescue analgesia (or when the Numeric Rating Scale score is 4 or greater).
Measured: Up to 24 hours post-block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsayed Ali Ibraheim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827157
- Sponsor's protocol ID
- Dexmedetomidine vs Dex in ESPB
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: A Prospective Randomized Double-Blind Controlled Study
- ClinicalTrials.gov ID
- NCT07827157
- Acronym / sponsor ID
- Dexmedetomidine vs Dex in ESPB
- Conditions
- Rib Fractures, Acute Pain, Thoracic Trauma
- Keywords
- Erector spinae plane block, ESPB, Dexmedetomidine, Dexamethasone, Bupivacaine, Ultrasound-guided regional anesthesia, Rib fracture analgesia, Diaphragmatic excursion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Sep 2026 (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.
Traumatic rib fractures cause severe chest wall pain that can impair normal breathing, coughing, and lung function. While systemic opioids are commonly used to treat traumatic pain, their side effects, such as sedation and respiratory depression, can complicate recovery. Regional nerve blocks like the ultrasound-guided erector spinae plane block (ESPB) offer targeted pain relief while minimizing opioid requirements.
The purpose of this clinical trial is to compare the analgesic efficacy and respiratory outcomes of adding dexmedetomidine versus dexamethasone to bupivacaine during an ultrasound-guided ESPB in emergency department patients with acute traumatic rib fractures.
Participants aged 18 to 65 years presenting within 24 hours of rib injury will be randomly assigned to one of two groups:
- Dexmedetomidine Group: Receives an ultrasound-guided ESPB with bupivacaine plus dexmedetomidine.
- Dexamethasone Group: Receives an ultrasound-guided ESPB with bupivacaine plus dexamethasone.
The primary outcome is the duration of analgesia, measured as the time to the first request for rescue pain medication. Secondary outcomes include pain scores at rest and during coughing/deep breathing, total 24-hour opioid consumption, diaphragmatic motion evaluated by ultrasound, respiratory recovery, and the incidence of adverse events over a 24-hour follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Active comparator | Drug: Dexmedetomidine with Bupivacaine in ESPBParticipants receive an ultrasound-guided erector spinae plane block (ESPB) with bupivacaine plus dexmedetomidine (0.5 mcg/kg) following local skin infiltration with 5 mL of 2% lidocaine. |
| Dexamethasone Group | Active comparator | Drug: Dexamethasone with Bupivacaine in ESPBParticipants receive an ultrasound-guided erector spinae plane block (ESPB) with bupivacaine plus dexamethasone (4 mg) following local skin infiltration with 5 mL of 2% lidocaine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients aged 18 to 65 years
- Both sexes
- American Society of Anesthesiologists (ASA) physical status I-II
- Acute traumatic rib fractures confirmed by appropriate imaging
- Flail-chest patients who are hemodynamically and respiratory stable to undergo erector spinae plane block (ESPB) and reliable assessment
Key exclusion criteria (13 listed)
- Patient refusal to participate
- Immediate need for endotracheal intubation or invasive mechanical ventilation prior to randomization or block placement
- Hemodynamic instability requiring immediate resuscitation or vasopressor support precluding safe regional anesthesia
- Cardiorespiratory arrest or peri-arrest status
- Severe associated traumatic brain injury or other injuries preventing reliable clinical evaluation
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 |
|---|---|---|
| Dexmedetomidine with Bupivacaine in ESPBUltrasound-guided thoracic erector spinae plane block (ESPB) administered deep to the erector spinae muscle and superficial to the transverse process (typically T4-T6) using bupivacaine supplemented with dexmedetomidine (0.5 mcg/kg) following local skin infiltration with 5 mL of 2% lidocaine. | Drug | Dexmedetomidine Group |
| Dexamethasone with Bupivacaine in ESPBUltrasound-guided thoracic erector spinae plane block (ESPB) administered deep to the erector spinae muscle and superficial to the transverse process (typically T4-T6) using bupivacaine supplemented with dexamethasone (4 mg) following local skin infiltration with 5 mL of 2% lidocaine. | Drug | Dexamethasone Group |
Primary outcome
Time to First Rescue Analgesic Request
Time frame: Up to 24 hours post-block
Time (in minutes) from the completion of the ultrasound-guided erector spinae plane block until the patient's first request for rescue analgesia (or when the Numeric Rating Scale score is 4 or greater).
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 18 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine with Bupivacaine in ESPB and Dexamethasone with Bupivacaine in ESPB in people with Rib Fractures and Acute Pain, 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 9 inclusion and 13 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: opening soon, as of the sponsor's last update on 18 Sep 2026. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Rescue Analgesic Request (time frame: Up to 24 hours post-block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026.