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

NCT07827157 — Phase 2 / Phase 3, Not yet recruiting, 100 participants, Assiut University

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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

Registry	NCT07827157
Status	Not yet recruiting
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	100 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Rib Fractures, Acute Pain, Thoracic Trauma
Interventions	Dexmedetomidine with Bupivacaine in ESPB, Dexamethasone with Bupivacaine in ESPB (Drug)
Dates	start 2026-10-01 (estimated), primary completion 2027-10-01 (estimated), completion 2027-11-01 (estimated), first posted 2026-09-18, last updated 2026-09-18

-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. 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Dexmedetomidine Group	Active comparator	Drug: Dexmedetomidine with Bupivacaine in ESPB	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.
Dexamethasone Group	Active comparator	Drug: Dexamethasone with Bupivacaine in ESPB	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.

Dexmedetomidine with Bupivacaine in ESPB (Drug): 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 ESPB (Drug): 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.

+Outcome measures

Primary outcomes

Time to First Rescue Analgesic Request [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).

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* 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
* Ability to report pain using a Numeric Rating Scale (NRS)
* Presentation within 24 hours of trauma
* Ability to provide written informed consent

Exclusion Criteria:

* 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
* 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