Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT05301634
Status:
UNKNOWN
Last Update Posted:
2022-05-24
First Post:
2022-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Bilateral Infraorbital Block Versus Intranasal Bupivacaine in Transsphenoidal Pituitary Adenoma Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-23', 'studyFirstSubmitDate': '2022-03-20', 'studyFirstSubmitQcDate': '2022-03-20', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean arterial blood pressure', 'timeFrame': 'at the time of mucosal dissection'}], 'secondaryOutcomes': [{'measure': 'Intraoperative need for magnesium sulphate', 'timeFrame': 'the entire duration of surgery', 'description': 'Intraoperative need for iv magnesium sulphate up to 3 mg to maintain blood pressure 20% below baseline'}, {'measure': 'Intraoperative need for fentanyl', 'timeFrame': 'the entire duration of surgery', 'description': 'Intraoperative need for iv fentanyl blouses 0.5 μg/kg (maximum total dose 5 μg/kg for the entire procedure) if no response to magnesium sulphate'}, {'measure': 'Intraoperative need for nitroglycerine', 'timeFrame': 'the entire duration of surgery', 'description': 'Intraoperative need for iv nitroglycerine infusion (5 - 100 mic/min iv) if no response to magnesium sulphate and fentanyl'}, {'measure': 'Postoperative need of pethidine', 'timeFrame': '24 hours postoprative', 'description': 'Postoperative need of pethidine boluses 25 mg with max.100 mg'}, {'measure': 'Postoperative pain assessed by Numeric pain score', 'timeFrame': '24 hours postoprative', 'description': 'Pain score will be assessed postoperatively (using the verbal Numeric Rating Scale \\[NRS\\] 0-100; 0 = Non ,100 = Worst imaginable pain)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraoperative Hypertension']}, 'descriptionModule': {'briefSummary': 'The study will evaluate the efficacy of bilateral infraorbital nerve block versus preoperative nasal packing with long-acting local anesthetic bupivacaine in term of maintaining hemodynamics intraoperative within 20% below baseline to achieve adequate hypotensive anesthesia and longer duration of postoperative analgesia up to 24 hours in patients undergoing transsphenoidal pituitary adenoma resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ASA I, II or III\n* patients scheduled to undergo endoscopic transsphenoidal approach to remove tumor under general anesthesia\n\nExclusion Criteria:\n\n* Patient's refusal\n* Allergy to local anesthetics.\n* Preoperative cerebrospinal fluid leak.\n* Preoperative cardiac arrythmias.\n* Seizure disorders.\n* Patients with severe endocrinal disorders that affecting the craniofacial morphology as acromegaly and cushinoid features."}, 'identificationModule': {'nctId': 'NCT05301634', 'briefTitle': 'Comparison Between Bilateral Infraorbital Block Versus Intranasal Bupivacaine in Transsphenoidal Pituitary Adenoma Resection', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparison Between Hemodynamic Effect of Bilateral Infraorbital Block Versus Intranasal Application of Bupivacaine in Patients Undergoing Transsphenoidal Pituitary Adenoma Resection.A Comparative Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'MS-532-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'the patients will receive bilateral infraorbital block', 'interventionNames': ['Procedure: infraorbital block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'the patients will receive topical intranasal application of bupivacaine', 'interventionNames': ['Procedure: topical intranasal bupivacaine']}], 'interventions': [{'name': 'infraorbital block', 'type': 'PROCEDURE', 'description': 'the patients will receive bilateral infraorbital block', 'armGroupLabels': ['Group A']}, {'name': 'topical intranasal bupivacaine', 'type': 'PROCEDURE', 'description': 'the patients will receive topical intranasal application of bupivacaine', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'abdelkhalek m Samy', 'role': 'CONTACT', 'email': 'dr.abdo86@gmail.com', 'phone': '01025854248'}, {'name': 'Eman M Mahmoud', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Khaled EL Elshafei', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mohamed F Elmahdy', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kasr Alaini hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anaesthesia', 'investigatorFullName': 'AbdElKhalik Mahmoud Shaban', 'investigatorAffiliation': 'Cairo University'}}}}