Ultrasound-guided regional nerve block versus general anesthesia for awake tympanoplasty
Official title: Safety and Efficacy of Regional Anesthesia for Awake Tympanoplasty Surgery: A Randomized Controlled Trial
Run by Zagazig University · NCT07275450 · Data updated 2026-11-12
This trial will test whether ultrasound-guided regional anesthesia can be used instead of general anesthesia for adults having elective tympanoplasty to improve recovery and pain control.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 65 Years |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig) |
| Status | Recruiting |
| Started | December 10, 2025 |
| Main results expected | September 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | December 11, 2025 |
| Trial ID | NCT07275450 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 21–65 years, ASA physical status I–II, who consent and are scheduled for elective unilateral tympanoplasty without contraindications to regional anesthesia are ideal candidates.
✕Probably not a fit
Patients with contraindications to regional anesthesia (coagulopathy, local infection, allergy to local anesthetic), significant comorbidities, pregnancy, or BMI >35 that impairs ultrasound visualization are unlikely to benefit from the regional approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults scheduled for elective unilateral tympanoplasty at Zagazig University Hospitals will receive either an ultrasound-guided regional nerve block for an awake procedure or standard general anesthesia, and the two groups will be compared on intraoperative and postoperative outcomes. Primary comparisons include time to discharge from the post-anesthesia care unit, intraoperative hemodynamics, quality of the surgical field, and block success rate (conversions to general anesthesia). Postoperative measures include pain scores (Numerical Rating Scale), time to first analgesic request, opioid consumption, and patient and surgeon satisfaction. The study will also monitor for block-related and surgery-related complications such as nerve injury, hematoma, local anesthetic toxicity, nausea, and vomiting.
Why it matters
Potential benefit: If successful, the approach could allow some tympanoplasty patients to have surgery awake with faster recovery, less opioid use, and potentially fewer anesthesia-related side effects.
How similar studies have gone: Smaller series and case reports have shown that targeted nerve blocks can be feasible for ear surgery, but high-quality comparative evidence remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients acceptance 2. Age: 21-65 years old 3. Sex: both sex (males or females). 4. Physical status: American Society Anesthesiologist (ASA) І and II. 5. Patients will be scheduled for elective unilateral tympanoplasty. Exclusion Criteria: 1. Contraindication of regional anesthesia: Coagulopathy or use of anticoagulant therapy -local infection at the site of injection- known allergy to local anesthetics (bupivacaine). 2. Neurological disorders affecting sensation in the head and neck. 3. Psychiatric illness, severe anxiety, or inability to cooperate during awake surgery. 4. History of previous neck or parotid surgery affecting nerve anatomy. 5. BMI \> 35 (if it may interfere with ultrasound visualization or landmark identification). 6. Pregnancy. 7. Advanced cardiovascular, respiratory, hepatic and renal diseases
Where it's running
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faculty of human medicine, Zagazig university hospitals
Zagazig, Egypt Recruiting
Study contacts
- Study coordinator: Dina Salem, MD
- Email: dinamaghraby@yahoo.com
- Phone: 0109933513
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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.