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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Dexmedetomidine GroupActive comparator 1 intervention
Group B: Dexamethasone GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Up to 24 hours post-block

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: