Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-03-04 @ 11:55 PM
Study NCT ID:
NCT03397069
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2017-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Midazolam Additive to Local Anesthetic in Peribulbar Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008874', 'term': 'Midazolam'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-10', 'studyFirstSubmitDate': '2017-12-23', 'studyFirstSubmitQcDate': '2018-01-05', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of the sensory and motor block', 'timeFrame': '6 hours', 'description': 'The quality of the sensory and motor block was assessed using the Ocular Anesthesia Scoring System (OASS). Patients were categorized into three groups according to the quality of the block and level of anesthesia achieved: poor (0-3), average (4-9) and good block (10-14)'}], 'secondaryOutcomes': [{'measure': 'Onset and duration of block', 'timeFrame': '6 hours', 'description': 'The onset of motor block (globe akinesia), sensory block, and lid akinesia (ptosis). Were recorded from the time of injection of (LAS) until complete globe akinesia, a disappearance of sensation, and complete lid akinesia (ptosis). Duration of globe akinesia was recorded till recurrence of muscle movements (score 8). Similarly, the return of sensation to the globe was assessed by digital spear pressure at the limbus.'}, {'measure': 'Analgesia', 'timeFrame': '4 hours postoperative', 'description': "Postoperative pain was assessed at 30 minutes' intervals utilizing verbal rating scale (VAS) on a scale of 0 to 10 (where 0 means no pain and 10 means the worst imaginable pain) for a period of 4 hours postoperative or until first analgesic request"}, {'measure': 'local or systemic complications', 'timeFrame': '6 hours', 'description': 'sub-conjunctival hematoma, itching, ecchymosis, diplopia, blindness, nausea, vomiting, dry mouth, and hypotension, were recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peribubar block - midazolam'], 'conditions': ['Postoperative Pain', 'Cataract', 'Local Anaesthetic Complication', 'Midazolam']}, 'referencesModule': {'references': [{'pmid': '30627737', 'type': 'DERIVED', 'citation': 'Ibrahim M, Gomaa E. Efficacy of midazolam addition to local anesthetic in peribulbar block : Randomized controlled trial. Anaesthesist. 2019 Mar;68(3):143-151. doi: 10.1007/s00101-018-0525-3. Epub 2019 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'Regional eye blocks are usually preferred for ophthalmic procedures. Peribulbar block (PBB) is a safe alternative for patients undergoing cataract surgery. Many studies tried to solve this issue by means of prolonging the duration of action of the local anesthetics used. Several drugs were tried as adjuncts to local anesthetics, and their effects have been studied. Midazolam added to the list of adjuvant used in the subarachnoid or epidural block can produce analgesia, probably mediated by the benzodiazepine-Gamma Amino-Butyric Acid(GABA) receptor complex.\n\nThe investigators hypothesized that the addition of midazolam to lidocaine will improve the quality of the peribulbar block; fasten the onset and prolonging its anesthetic and analgesic duration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 90 adult patients with ASA physical status I to III\n* Aged 40-70 years\n* Scheduled for elective extracapsular or phacoemulsification cataract surgery with peribulbar block\n* No history of allergy to local anesthetics\n* Axial length less than 28 mm.\n\nExclusion Criteria:\n\n* Patient's refusal to share in the study\n* communication barrier (e.g. impaired hearing, disturbed conscious level, impaired mental status)\n* uncontrolled tremors\n* morbidly obese patients\n* allergy to lidocaine\n* coagulation abnormalities\n* glaucoma\n* recent surgical procedure on the same eye."}, 'identificationModule': {'nctId': 'NCT03397069', 'briefTitle': 'Midazolam Additive to Local Anesthetic in Peribulbar Block', 'organization': {'class': 'OTHER', 'fullName': 'Al Jedaani Hospital'}, 'officialTitle': 'Efficacy of Midazolam Addition to Local Anesthetic in Peribulbar Block. Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': 'AlJedaaniH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group C(control)', 'description': 'Peribulbar block without midazolam (peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml)', 'interventionNames': ['Procedure: Peribulbar block (control)']}, {'type': 'EXPERIMENTAL', 'label': 'Group M1', 'description': 'Peribulbar block with midazolam 50 µg (peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 50 µg/ml)', 'interventionNames': ['Procedure: Peribulbar block(M1)']}, {'type': 'EXPERIMENTAL', 'label': 'Group M2', 'description': 'Peribulbar block with midazolam 100 µg(peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 100 µg/ml', 'interventionNames': ['Procedure: Peribulbar block(M2)']}], 'interventions': [{'name': 'Peribulbar block (control)', 'type': 'PROCEDURE', 'otherNames': ['Peribulbar block without midazolam'], 'description': 'The Peribulbar block was performed by inserting the needle percutaneously at the area bounded by 1- The imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit, laterally 2- Lateral border of the nose, medially 3- Inferior lacrimal canaliculus, superiorly and 4- Inferior orbital margin, inferiorly. The needle was introduced in an anteroposterior direction to its half-length and then in an oblique direction to the optical foramen.\n\nAfter negative aspiration, 6-8 ml of local anesthetic solution (lidocaine 2%, hyaluronidase 15 IU / ml ) was injected slowly over about 40 seconds or until the appearance of lid fullness. This was followed by a gentle digital massage to the eyeball to facilitate diffusion of the local anesthetic mixture.', 'armGroupLabels': ['Group C(control)']}, {'name': 'Peribulbar block(M1)', 'type': 'PROCEDURE', 'otherNames': ['Peribulbar block with midazolam 50ug'], 'description': 'The Peribulbar block was performed by inserting the needle percutaneously at the area bounded by 1- The imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit, laterally 2- Lateral border of the nose, medially 3- Inferior lacrimal canaliculus, superiorly and 4- Inferior orbital margin, inferiorly. The needle was introduced in an anteroposterior direction to its half-length and then in an oblique direction to the optical foramen.\n\nAfter negative aspiration, 6-8 ml of local anesthetic solution (lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 50 µg/ml ) was injected slowly over about 40 seconds or until the appearance of lid fullness. This was followed by a gentle digital massage to the eyeball to facilitate diffusion of the local anesthetic mixture.', 'armGroupLabels': ['Group M1']}, {'name': 'Peribulbar block(M2)', 'type': 'PROCEDURE', 'otherNames': ['Peribulbar block with midazolam 100ug'], 'description': 'The Peribulbar block was performed by inserting the needle percutaneously at the area bounded by 1- The imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit, laterally 2- Lateral border of the nose, medially 3- Inferior lacrimal canaliculus, superiorly and 4- Inferior orbital margin, inferiorly. The needle was introduced in an anteroposterior direction to its half-length and then in an oblique direction to the optical foramen.\n\nAfter negative aspiration, 6-8 ml of local anesthetic solution (lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 100 µg/ml ) was injected slowly over about 40 seconds or until the appearance of lid fullness. This was followed by a gentle digital massage to the eyeball to facilitate diffusion of the local anesthetic mixture.', 'armGroupLabels': ['Group M2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21462/7500', 'city': 'Jeddah', 'state': 'Meccah', 'country': 'Saudi Arabia', 'facility': 'Al Jedaani group of hospitals', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al Jedaani Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}