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Dexmedetomidine vs Dexamethasone in ESPB for Traumatic Rib Fractures

NCT07827157Phase 3

Key facts

Status: Not yet recruiting
Start: Oct 2026
Primary completion: Oct 2027
Sponsor: Assiut University

Drugs: dexmedetomidinedexamethasone
Conditions: acute painrib fracture

Overview

Phase 3, randomised, double-blind trial in acute pain and rib fracture comparing Dexmedetomidine Group with Dexamethasone Group (2 arms). Primary endpoint: Time to First Rescue Analgesic Request. Planned start Oct 2026; status: not yet recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Dexmedetomidine Group
Ultrasound-guided ESPB with bupivacaine plus dexmedetomidine (0.5 mcg/kg).
Dexamethasone Group
Ultrasound-guided ESPB with bupivacaine plus dexamethasone (4 mg).

Who it enrols

Adult patients aged 18 to 65 years with acute traumatic rib fractures presenting within 24 hours of trauma, who are hemodynamically and respiratory stable, excluding those requiring immediate intubation, with severe associated injuries, coagulopathy, or chronic opioid consumption.

Endpoints

Primary

Time to First Rescue Analgesic RequestUp to 24 hours post-block

Secondary

Pain scores at restUp to 24 hours
Pain scores during coughing/deep breathingUp to 24 hours
Total 24-hour opioid consumption24 hours
Diaphragmatic motion evaluated by ultrasoundUp to 24 hours
Respiratory recoveryUp to 24 hours
Incidence of adverse eventsUp to 24 hours

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