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Clinical Trials/NCT07275450
NCT07275450
Recruiting
Not Applicable

Safety and Efficacy of Regional Anesthesia for Awake Tympanoplasty Surgery: A Randomized Controlled Trial

Zagazig University1 site in 1 country128 target enrollmentStarted: December 10, 2025Last updated:
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Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
128
Locations
1
Primary Endpoint
The time of discharge from Post Anesthesia Care Unit (PACU)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The aim of this study to evaluate efficacy of ultrasound guided regional anesthesia in performing awake tympanoplasty surgery versus traditional general anesthesia

Detailed Description

  • To evaluate ultrasound-guided regional anesthesia versus general anesthesia in patients undergoing tympanoplasty as regards:
  • To assess the time of discharge from post anesthesia care unit
  • To assess intraoperative hemodynamic parameters, quality of the surgical field and the block success rate (number of patients converted to general anesthesia).
  • To assess postoperative parameters: Numerical Rating Scale , time to first request of analgesia, postoperative opioid consumption, patient and surgeon satisfaction in both groups.
  • To assess the incidence of block-related complications (such as nerve injury, hematoma, inadequate block, or local anesthetic toxicity) or surgery related complications as nausea and vomiting

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients acceptance
  • •Age: 21-65 years old
  • •Sex: both sex (males or females).
  • •Physical status: American Society Anesthesiologist (ASA) І and II.
  • •Patients will be scheduled for elective unilateral tympanoplasty.

Exclusion Criteria

  • •Contraindication of regional anesthesia: Coagulopathy or use of anticoagulant therapy -local infection at the site of injection- known allergy to local anesthetics (bupivacaine).
  • •Neurological disorders affecting sensation in the head and neck.
  • •Psychiatric illness, severe anxiety, or inability to cooperate during awake surgery.
  • •History of previous neck or parotid surgery affecting nerve anatomy.
  • •BMI \> 35 (if it may interfere with ultrasound visualization or landmark identification).
  • •Advanced cardiovascular, respiratory, hepatic and renal diseases

Outcomes

Primary Outcomes

The time of discharge from Post Anesthesia Care Unit (PACU)

Time Frame: 2 hours postoperative

The time from arrival to the Post Anesthesia Care Unit (PACU) to the time to discharge to the ward according to modified aldrete score

Secondary Outcomes

  • The incidence of block-related complications or surgery related complications(24 hours)
  • Intraoperative mean arterial blood pressure(0 minute (basal) and every 5 minutes up to 2 hours)
  • Surgeon satisfaction(duration of surgery (intraoperative))
  • Intraoperative heart rate ( beat per minute)(before starting anesthesia 0 minute (basal )and every 5 minutes up to 2 hours)
  • Pain intensity by using Numerical Rating Scale (NRS)(Post Anesthesia Care Unit (0 hour) , 2 hours, 4 hours, 8 hours, 12 hours and 24 hours)
  • Block success rate(15-20 minutes (from finishing block till start surgery))
  • Quality of surgical field(duration of surgery (intraoperative))
  • Time to first request of analgesia(24 hours)
  • Total postoperative analgesic consumption(24 hours)
  • Patient satisfaction by Likert score(24 hours)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Dina Abdelhameed Elsadek Salem

Associate professor of anesthesia

Zagazig University

Study Sites (1)

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