Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-25 @ 2:39 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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To evaluate ultrasound-guided regional anesthesia versus general anesthesia in patients undergoing tympanoplasty'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2025-12-07', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time of discharge from Post Anesthesia Care Unit (PACU)', 'timeFrame': '2 hours postoperative', 'description': 'The time from arrival to the Post Anesthesia Care Unit (PACU) to the time to discharge to the ward according to modified aldrete score'}], 'secondaryOutcomes': [{'measure': 'Intraoperative mean arterial blood pressure', 'timeFrame': '0 minute (basal) and every 5 minutes up to 2 hours', 'description': 'Intraoperative changes in mean arterial blood pressure (mmHg)'}, {'measure': 'Pain intensity by using Numerical Rating Scale (NRS)', 'timeFrame': 'Post Anesthesia Care Unit (0 hour) , 2 hours, 4 hours, 8 hours, 12 hours and 24 hours', 'description': 'It is a scale from 0 to 10, where 0=no pain and 10= worst pain'}, {'measure': 'Block success rate', 'timeFrame': '15-20 minutes (from finishing block till start surgery)', 'description': 'The number of patients converted to general anesthesia'}, {'measure': 'Quality of surgical field', 'timeFrame': 'duration of surgery (intraoperative)', 'description': 'quality of surgical field by Modena Bleeding Score (MBS) is a validated categorical scale designed to measure the quality of the surgical field in relation to bleeding during endoscopic surgery. It features five grades (1= no bleeding, 2= bleeding easily controlled by suction, 3= bleeding that slows surgical procedure, 4= most maneuvers are dedicated to bleeding control and 5= bleeding is so sever that only procedures aimed at controlling bleeding)'}, {'measure': 'Time to first request of analgesia', 'timeFrame': '24 hours', 'description': 'Time to first request of analgesia (pethidine)'}, {'measure': 'Total postoperative analgesic consumption', 'timeFrame': '24 hours', 'description': 'total postoperative pethidine consumption'}, {'measure': 'Patient satisfaction by Likert score', 'timeFrame': '24 hours', 'description': 'patient satisfaction by Likert score: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)'}, {'measure': 'Surgeon satisfaction', 'timeFrame': 'duration of surgery (intraoperative)', 'description': 'Surgeon satisfaction by asking the surgeon to rate satisfaction at the end of surgery (4 =excellent, 3=good, 2=fair, 1=poor, 0=extremely poor)'}, {'measure': 'The incidence of block-related complications or surgery related complications', 'timeFrame': '24 hours', 'description': 'To assess the incidence of block-related complications, such as nerve injury, hematoma, inadequate block, or local anesthetic toxicity or surgery related complications (e.g. nausea and vomiting)'}, {'measure': 'Intraoperative heart rate ( beat per minute)', 'timeFrame': 'before starting anesthesia 0 minute (basal )and every 5 minutes up to 2 hours', 'description': 'measure intraoperative changes in heart rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound guided regional anesthesia', 'General anesthesia', 'Awake tympanoplasty'], 'conditions': ['Ultrasound Guided Nerve Block', 'Anesthesia , Analgesia']}, 'descriptionModule': {'briefSummary': 'The aim of this study to evaluate efficacy of ultrasound guided regional anesthesia in performing awake tympanoplasty surgery versus traditional general anesthesia', 'detailedDescription': '* To evaluate ultrasound-guided regional anesthesia versus general anesthesia in patients undergoing tympanoplasty as regards:\n* To assess the time of discharge from post anesthesia care unit\n* To assess intraoperative hemodynamic parameters, quality of the surgical field and the block success rate (number of patients converted to general anesthesia).\n* To assess postoperative parameters: Numerical Rating Scale , time to first request of analgesia, postoperative opioid consumption, patient and surgeon satisfaction in both groups.\n* 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients acceptance\n2. Age: 21-65 years old\n3. Sex: both sex (males or females).\n4. Physical status: American Society Anesthesiologist (ASA) І and II.\n5. Patients will be scheduled for elective unilateral tympanoplasty.\n\nExclusion Criteria:\n\n1. Contraindication of regional anesthesia: Coagulopathy or use of anticoagulant therapy -local infection at the site of injection- known allergy to local anesthetics (bupivacaine).\n2. Neurological disorders affecting sensation in the head and neck.\n3. Psychiatric illness, severe anxiety, or inability to cooperate during awake surgery.\n4. History of previous neck or parotid surgery affecting nerve anatomy.\n5. BMI \\> 35 (if it may interfere with ultrasound visualization or landmark identification).\n6. Pregnancy.\n7. Advanced cardiovascular, respiratory, hepatic and renal diseases'}, 'identificationModule': {'nctId': 'NCT07275450', 'briefTitle': 'Comparative Study Between Ultrasound Guided Regional Anesthesia for Awake Tympanoplasty Surgery vs General Anesthesia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Safety and Efficacy of Regional Anesthesia for Awake Tympanoplasty Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1841'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound-guided regional anesthesia group', 'description': 'patients will receive regional anesthesia using ultrasound guidance. Target nerves (e.g., great auricular nerve, auriculotemporal nerve and lesser occipital nerve) will be identified and anesthetized under real-time ultrasound visualization to ensure accurate needle placement and local anesthetic spread.', 'interventionNames': ['Procedure: Ultrasound-guided regional anesthesia group']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'patients will receive general anesthesia', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Ultrasound-guided regional anesthesia group', 'type': 'PROCEDURE', 'description': 'patients will receive regional anesthesia using ultrasound guidance. Target nerves (e.g., great auricular nerve, auriculotemporal nerve and lesser occipital nerve) will be identified and anesthetized under real-time ultrasound visualization to ensure accurate needle placement and local anesthetic spread.', 'armGroupLabels': ['Ultrasound-guided regional anesthesia group']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'patients will receive general anesthesia.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Hegab, MD', 'role': 'CONTACT', 'email': 'dinamaghraby@yahoo.com', 'phone': '01000089347', 'phoneExt': '002'}], 'facility': 'faculty of human medicine, Zagazig university hospitals', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'centralContacts': [{'name': 'Dina Salem, MD', 'role': 'CONTACT', 'email': 'dinamaghraby@yahoo.com', 'phone': '0109933513', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of anesthesia', 'investigatorFullName': 'Dina Abdelhameed Elsadek Salem', 'investigatorAffiliation': 'Zagazig University'}}}}