Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 3:50 PM
Study NCT ID:
NCT01258959
Status:
COMPLETED
Last Update Posted:
2011-06-09
First Post:
2010-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anaesthesia for Ophthalmic Surgery: How "Retro" is the Peribulbar Block?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-08', 'studyFirstSubmitDate': '2010-12-08', 'studyFirstSubmitQcDate': '2010-12-10', 'lastUpdatePostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of detectable retrobulbar spread of local anaesthetics during peribulbar injection.', 'timeFrame': 'At start (During peribulbar injection)', 'description': 'The outcome measure is the description of the spread of local anesthetics during the injection of the drug via the parabulbar needle.'}], 'secondaryOutcomes': [{'measure': 'Assessment of block quality', 'timeFrame': '20 Minutes after block', 'description': 'Assessment of the block quality by ophthalmic surgeon just before surgery starts and at least 20 minutes after the block: complete akinesia and anaesthesia or partial akinesia/anaesthesia.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ultrasound, retrobulbar, parabulbar, ophthalmic surgery.'], 'conditions': ['Ophthalmic Surgery', 'Parabulbar Block']}, 'referencesModule': {'references': [{'pmid': '18948389', 'type': 'BACKGROUND', 'citation': 'Luyet C, Eichenberger U, Moriggl B, Remonda L, Greif R. Real-time visualization of ultrasound-guided retrobulbar blockade: an imaging study. Br J Anaesth. 2008 Dec;101(6):855-9. doi: 10.1093/bja/aen293. Epub 2008 Oct 23.'}, {'pmid': '11135722', 'type': 'BACKGROUND', 'citation': 'Ripart J, Lefrant JY, de La Coussaye JE, Prat-Pradal D, Vivien B, Eledjam JJ. Peribulbar versus retrobulbar anesthesia for ophthalmic surgery: an anatomical comparison of extraconal and intraconal injections. Anesthesiology. 2001 Jan;94(1):56-62. doi: 10.1097/00000542-200101000-00013.'}, {'pmid': '1854695', 'type': 'BACKGROUND', 'citation': 'Ropo A, Nikki P, Ruusuvaara P, Kivisaari L. Comparison of retrobulbar and periocular injections of lignocaine by computerised tomography. Br J Ophthalmol. 1991 Jul;75(7):417-20. doi: 10.1136/bjo.75.7.417.'}]}, 'descriptionModule': {'briefSummary': 'Ophthalmic surgery on the posterior section of the eye can either be performed under general anaesthesia or under local aneasthesia. The local anaesthesia is performed by injecting local anaesthetics behind the eye. There are two techniques: Either the needle is placed into the muscle cone formed by the four recti muscles - this is called intraconal or retrobulbar block, or the needle is placed outside of the muscle cone - this would be called extraconal or peribulbar. In our hospital the investigators usually perform the peribulbar block since it is easier to perform and has a smaller risk to injure the eye. The investigators however realize that the parabulbar block is sometimes very efficient and sometimes not, thus requiring a second or third injection. Now investigators are able to visualize where the local anaesthetics spreads with the help of ultrasound imaging. The aim of the study is to observe and to describe the incidence of intraconal spread of local anaesthetics when a peribulbar block is performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 consecutive patients (men and women) of at least 18 years of age undergoing an ophthalmic procedure on the posterior section of the eye under local anaesthesia, i.e. with a peribulbar block.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-informed consent\n\nExclusion Criteria:\n\n* coagulation disorder\n* INR over 1.5 and/or a platelet count less than 75 X 109/L,\n* pathological myopia,\n* inability of the patient to lie down for the operation for more than 2 hours\n* lack of informed consent.'}, 'identificationModule': {'nctId': 'NCT01258959', 'briefTitle': 'Anaesthesia for Ophthalmic Surgery: How "Retro" is the Peribulbar Block?', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Anaesthesia for Ophthalmic Surgery: How "Retro" is the Peribulbar Block?', 'orgStudyIdInfo': {'id': 'Retro-Parabulbar'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ophthalmic surgery patients', 'description': 'Patients (men and women) of at least 18 years of age undergoing an ophthalmic procedure on the posterior section of the eye under local anaesthesia, i.e. with a peribulbar block. Inclusion and exclusion criteria for the study are the same as for the peribulbar anaesthesia.', 'interventionNames': ['Procedure: Ultrasound detection of local anesthetics spread']}], 'interventions': [{'name': 'Ultrasound detection of local anesthetics spread', 'type': 'PROCEDURE', 'description': 'During the parabulbar injection the ultrasound operator experienced in ultrasound guided retrobulbar block will assess whether there is spread of local anaesthetic in the central cone just behind the sclera (yes or no). The anaesthesist performing the block will be blinded to the ultrasound visualized spread of local anaesthetic.', 'armGroupLabels': ['Ophthalmic surgery patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Science Centres', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Paul McHardy', 'oldOrganization': 'Sunnybrook Health Science Centre'}}}}