Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-02-01 @ 6:51 PM
Study NCT ID:
NCT03312959
Status:
UNKNOWN
Last Update Posted:
2017-10-18
First Post:
2017-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heavy Bupivacaine in Peribulbar Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-13', 'studyFirstSubmitDate': '2017-10-13', 'studyFirstSubmitQcDate': '2017-10-13', 'lastUpdatePostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The onset and duration of lid and globe akinesia', 'timeFrame': '12 hours postoperative', 'description': 'scoring the ocular movements in each direction of gaze'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthetics, Local']}, 'descriptionModule': {'briefSummary': 'Most of the ophthalmic procedures are performed under local anesthesia as the patient is often elderly and with diseases. This may increase the risk of morbidity and mortality under general anesthesia. Different eye blocks have been practiced with great success. Moreover, it is associated with less hemodynamic instability, less respiratory depression, better postoperative pain relief, and less nausea and vomiting than general anesthesia. It is also associated with a reduction in stress response, maintained oxygen saturation and cardiovascular stability, in addition to the production of good akinesia and anesthesia alleviating occulo-medullary reflexes, all make local anesthesia more superior and safe technique.', 'detailedDescription': 'Peribulbar anesthesia is widely practiced now as a safe local block for cataract eye surgeries. However, the limited duration of these blocks was shown to be the main problem encountered intra-operatively. Therefore, additional top-up doses are usually needed to continue the operation. Many kinds of research tried to introduce solutions in order to prolong the duration of the local anesthetics used. Many researchers tried different volumes, doses and adjuvant to local anesthetics, and studied their effects There are many studies that evaluated the effect of baricity of local anesthetic on the potency of motor block and the duration of motor and sensory blockade.\n\nHowever, no properly designed randomized, controlled studies have evaluated the feasibility and reliability of baricity local anesthetic agents used for the peribulbar block.\n\nAim of the work prospective, randomized study was conducted to evaluate the effects of the baricitized bupivacaine used for the peribulbar block in patients undergoing posterior segment surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with American Society of Anesthesiology (ASA) I or II.\n* 30-80 years old\n* Patients scheduled for elective unilateral posterior segment surgeries.\n\nExclusion Criteria:\n\n* Patient's refusal.\n* orbital deformity\n* axial length( \\>28 mm )\n* increased intraocular pressure, or if they were blind in the contralateral eye, international normalized ratio (INR) \\> 1.5\n* allergy to local anesthetics, mentally retarded patients"}, 'identificationModule': {'nctId': 'NCT03312959', 'briefTitle': 'Heavy Bupivacaine in Peribulbar Block', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Heavy Bupivacaine Versus Plain Bupivacaine in Peribulbar Block', 'orgStudyIdInfo': {'id': 'badway 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hyperbaric bupvacaine group', 'description': 'Peribulbar block will be performed using a total volume of 7 ml 6ml hyperbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline', 'interventionNames': ['Drug: hyperbaric bupvacaine in Peribulbar block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'isobaric bupvacaine group', 'description': 'Peribulbar block will be performed using a total volume of 7 ml 6ml isorbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline', 'interventionNames': ['Drug: isobaric bupvacaine in Peribulbar block']}], 'interventions': [{'name': 'hyperbaric bupvacaine in Peribulbar block', 'type': 'DRUG', 'otherNames': ['trial group'], 'description': 'hyperbaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery', 'armGroupLabels': ['hyperbaric bupvacaine group']}, {'name': 'isobaric bupvacaine in Peribulbar block', 'type': 'DRUG', 'otherNames': ['control group'], 'description': 'isobaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery', 'armGroupLabels': ['isobaric bupvacaine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1234', 'city': 'Cairo', 'state': 'Giza Governorate', 'country': 'Egypt', 'facility': 'Cairo University'}], 'centralContacts': [{'name': 'Hassan Ali', 'role': 'CONTACT', 'email': 'hassan364@hotmail.com', 'phone': '1001733687'}, {'name': 'Ahmed Badwy', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia', 'investigatorFullName': 'Hassan Mohamed Ali', 'investigatorAffiliation': 'Cairo University'}}}}