Ultrasound-guided regional nerve block versus general anesthesia for awake tympanoplasty
Safety and Efficacy of Regional Anesthesia for Awake Tympanoplasty Surgery: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig) |
| Trial ID | NCT07275450 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Smaller series and case reports have shown that targeted nerve blocks can be feasible for ear surgery, but high-quality comparative evidence remains limited.
Eligibility criteria
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 this trial is running
Zagazig
- faculty of human medicine, Zagazig university hospitals — Zagazig, Egypt (Recruiting)
Study contacts
- Study coordinator: Dina Salem, MD
- Email: dinamaghraby@yahoo.com
- Phone: 0109933513
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.