Dexmedetomidine added to a nerve block for middle ear surgery
Official title: Efficacy of Dexmedetomidine as an Adjuvant to Ultrasound-Guided Greater Auricular Nerve Block for Middle Ear Surgeries: A Randomized Double-Blinded Controlled Study
Run by Minia University · NCT07878533 · Data updated 2026-11-12
In adults having elective middle ear surgery, this trial tests whether adding dexmedetomidine to bupivacaine for a greater auricular nerve block can extend pain relief after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Minia University Academic / other |
| Locations | 1 site (Minya) |
| Status | Recruiting |
| Started | September 25, 2026 |
| Main results expected | April 30, 2027 |
| Study ends | May 30, 2027 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07878533 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-70 years undergoing elective middle ear surgery under general anesthesia, ASA I-II, BMI ≤ 35 kg/m2.
✕Probably not a fit
Patients who do not experience extended analgesia or who have adverse reactions to dexmedetomidine may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, controlled Phase 2 trial comparing two nerve block regimens given under ultrasound guidance before anesthesia induction. One group receives bupivacaine alone, the other receives bupivacaine plus dexmedetomidine, with all patients receiving standard general anesthesia and a uniform rescue analgesia plan. Outcomes tracked include duration of analgesia, pain scores, opioid consumption, emergence agitation, hemodynamics, and adverse effects over 24 hours postoperatively. The study uses computer-generated randomization and sealed envelopes, with outcome assessors blinded to group allocation. Forty adults with ASA I-II undergoing elective middle ear surgery are enrolled.
Why it matters
Potential benefit: If successful, the dexmedetomidine adjuvant could prolong pain relief and reduce opioid needs after middle ear surgery.
How similar studies have gone: Previous work in regional anesthesia has shown that dexmedetomidine can prolong block duration in various nerve blocks, suggesting potential for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Minia university hospital
Minya, Egypt Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.