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Recruiting Phase 2

Dexmedetomidine as an Adjuvant to Greater Auricular Nerve Block in Middle Ear Surgeries

NCT07878533 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 2
Started
2026-09-25
Last updated
2026-10-16

Condition(s) studied

Postoperative PainMiddle Ear Surgery

Investigational drug(s) / intervention(s)

Bupivacaine →Dexmedetomidine →Normal salineUltrasound-guided greater auricular nerve block

Bupivacaine: 2 ml of bupivacaine 0.25% injected around the greater auricular nerve under ultrasound guidance before induction of general anesthesia.

Dexmedetomidine: 1 ml of dexmedetomidine 0.5 µg/kg added to bupivacaine in the greater auricular nerve block.

Normal saline: 1 ml of normal saline 0.9% added to 2 ml bupivacaine 0.25% in the greater auricular nerve block.

Ultrasound-guided greater auricular nerve block: Ultrasound-guided block of the greater auricular nerve performed before induction of general anesthesia in both groups.

Study summary

This randomized, double-blind, controlled study will evaluate whether adding dexmedetomidine to bupivacaine in an ultrasound-guided greater auricular nerve block prolongs pain relief after middle ear surgery. Adults undergoing elective middle ear surgery under general anesthesia will receive the block before induction, either with bupivacaine alone or with bupivacaine plus dexmedetomidine. The main outcome is how long pain relief lasts after the block. Other outcomes include pain scores, opioid use, emergence agitation, hemodynamic changes, and side effects.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Inclusion Criteria: * Patients scheduled for elective middle ear surgery under general anesthesia * Aged 18-70 years * ASA physical status I or II * BMI ≤ 35 kg/m2 Exclusion Criteria: * Patient refusal * Known allergy to local anesthetics or dexmedetomidine * Coagulation disorders or anticoagulant therapy * Infection at the injection site * History of head and neck surgery * Significant cardiovascular disease (heart block, severe bradycardia, or uncontrolled hypertension) * Hepatic or renal impairment * Chronic opioid or analgesic use * Psychiatric disorders or inability to cooperate * Pregnancy or lactation

Primary outcome measure(s)

  • Duration of Analgesia — 24 hours after surgery
    Time from completion of the greater auricular nerve block until the patient's first request for rescue analgesia after surgery.

Trial sites (1)

FacilityCityRegionStatus
Minia university hospital Minya Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07878533 on ClinicalTrials.gov ↗ ← All trials in Egypt