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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Minia University • ClinicalTrials.gov ID: NCT07878533

Registry updated: 2026-10-16
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Description

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.

Interventions

  • Bupivacaine (Drug)
    2 ml of bupivacaine 0.25% injected around the greater auricular nerve under ultrasound guidance before induction of general anesthesia.
  • Dexmedetomidine (Drug)
    1 ml of dexmedetomidine 0.5 µg/kg added to bupivacaine in the greater auricular nerve block.
  • Normal saline (Drug)
    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 (Procedure)
    Ultrasound-guided block of the greater auricular nerve performed before induction of general anesthesia in both groups.

Eligibility criteria

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

Conditions

Postoperative Pain Middle Ear Surgery

Locations

  • Minia university hospital — Minya, Egypt
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record