Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
Study NCT ID:
NCT07275450
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study Between Ultrasound Guided Regional Anesthesia for Awake Tympanoplasty Surgery vs General Anesthesia
Sponsor:
Zagazig University
Organization:
Study Overview
Official Title:
Safety and Efficacy of Regional Anesthesia for Awake Tympanoplasty Surgery: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
* 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: