Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-31 @ 2:52 AM
Study NCT ID:
NCT07000669
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bilateral Peribulbar Block for Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-05-24', 'studyFirstSubmitQcDate': '2025-05-24', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of pain', 'timeFrame': 'Intraoperatively', 'description': 'The pain will be evaluated by straightforward questioning using a 3-point scoring method (no pain = 0, discomfort = 1, pain = 2) during the procedure.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': '24 hours postoperatively', 'description': 'The point in time to satisfactory surgical anesthesia will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)'}, {'measure': 'Grading of Akinesia', 'timeFrame': 'Intraoperatively', 'description': 'Motor block will be assessed by estimation of globe akinesia in the four quadrants, discriminated by the 4 directions of the gaze: lateral, medial, superior, and inferior. A 3- point scoring method will be chosen, in which 0 = akinesia, 1 = incomplete akinesia, and 2 = natural movement, with a total score ranging from 0-8 for the four muscles.'}, {'measure': 'Incidence of adverse events', 'timeFrame': '24 hours postoperatively', 'description': 'Incidence of adverse events such as coughing, vomiting, hypotension, bradycardia, tachycardia, arrhythmias, proptosis, globe puncture, or retrobulbar hemorrhage will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety', 'Efficacy', 'Bilateral', 'Peribulbar Block', 'Cataract Surgery']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the safety and efficacy of bilateral peribulbar block for cataract surgery.', 'detailedDescription': 'Cataract surgery is one of the most commonly performed procedures worldwide, with local anesthesia being the preferred method due to its safety, efficacy, and cost-effectiveness.\n\nPeribulbar anaesthesia has gained popularity due to its relative efficacy in generating ocular akinesia and anaesthesia with a reduced risk of consequences such as optic nerve damage and globe perforation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This Case series interventional study will be carried out on 50 patients undergoing cataract surgery at Tanta University Hospitals.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Both sexes.\n* American Society of Anesthesiology (ASA) physical status I-III.\n* Patients undergoing cataract surgery\n\nExclusion Criteria:\n\n* Infection at the site of the surgery.\n* Allergy to any of the used drugs.\n* Coagulopathy.\n* Posterior staphyloma.\n* Bronchial asthma.\n* Bradyarrhythmia.\n* Pre-existing ocular muscle paresis.\n* Neurological deficit.\n* Co-existing inflammatory conditions of eye.\n* Complicated cataracts.\n* Previously operated eyes.'}, 'identificationModule': {'nctId': 'NCT07000669', 'briefTitle': 'Bilateral Peribulbar Block for Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Safety and Efficacy of Bilateral Peribulbar Block for Cataract Surgery', 'orgStudyIdInfo': {'id': '36264PR1192/4/25.'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peribulbar anesthesia group', 'description': 'Patients undergoing bilateral peribulbar anesthesia for cataract surgery', 'interventionNames': ['Other: Bilateral peribulbar block']}], 'interventions': [{'name': 'Bilateral peribulbar block', 'type': 'OTHER', 'description': 'Patients undergoing bilateral peribulbar anesthesia for cataract surgery.', 'armGroupLabels': ['Peribulbar anesthesia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed I Elshahawy, MD', 'role': 'CONTACT', 'email': 'ahmedelshahawy852@gmail.com', 'phone': '00966568458735'}, {'name': 'Mohammed S ElSharkawy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Ahmed I Elshahawy, MD', 'role': 'CONTACT', 'email': 'ahmedelshahawy852@gmail.com', 'phone': '00966568458735'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Anesthesiology, MAGRABI Hospital and Centers, Kingdom of Saudi Arabia', 'investigatorFullName': 'Ahmed Ibrahim Elshahawy', 'investigatorAffiliation': 'Tanta University'}}}}