Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-07 @ 9:21 AM
Study NCT ID:
NCT06423859
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Articaine Plus Dexmedetomidine in Supraclavicular Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002355', 'term': 'Carticaine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-16', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensory block duration', 'timeFrame': '24 hours post block', 'description': 'the time between the onset of sensory block to the complete resolution of anesthesia on all nerves distribution.'}], 'secondaryOutcomes': [{'measure': 'onset time of sensory block', 'timeFrame': '15 minutes after block', 'description': 'The time between the end of the drug injection and the total abolition of pinprick sensation along the distribution of any of nerves - median, ulnar, radial, or musculocutaneous'}, {'measure': 'onset time for motor block', 'timeFrame': '15 minutes after block', 'description': 'the time between the end of the drug injection and Grade 1 motor block'}, {'measure': 'motor duration block', 'timeFrame': '24 hours post block', 'description': 'the time interval between the onset time of motor block and the recovery of complete motor function of that limb'}, {'measure': 'Analgesia time', 'timeFrame': '24 hours postoperative', 'description': 'time interval between the administration of local anesthesia solution and onset of pain at surgical site'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain, Acute']}, 'descriptionModule': {'briefSummary': 'Articaine has emerged as a local anesthetic (LA) that produces sensory and motor blockade shorter than bupivacaine and lower in neurotoxicity than lidocaine.\n\nStudies have shown that adding dexmedetomidine to LA produces prolongation of sensory and motor bock duration.\n\nEarly regain of motor power with adequate analgesia is needed in ambulatory surgery, for early start of physiotherapy. This study was designed to test efficacy of adding dexmedetomidine to articaine on the duration of sensory and motor block.', 'detailedDescription': 'Articaine is an amide LA produced in the 1960s and first used in clinical trials in 1974. Although it is an amide that is similar to prilocaine in chemical structure, it contains a thiophene ring rather than a benzene ring. Articaine is a rapid and short acting LA, which has low neurotoxicity and appears to diffuse through tissues more readily than other commonly used LA agents. It is metabolized by nonspecific plasma esterases both in blood and tissues, leading to its rapid clearance.\n\nα2-adrenergic receptor agonists have been the focus of interest for their sedative, analgesic, perioperative sympatholytic, and cardiovascular stabilizing effects along with providing reduction in anesthetic requirements. Dexmedetomidine may act on supraspinal (locus coeruleus) or spinal level or peripheral α2-adrenoreceptor to reduce nociceptive transmission, leading to analgesia.\n\nPrevious trials focused on adding dexmedetomidine to either levobupivacaine and bupivacaine, found augmentation of both sensory and motor block along with prolonged duration of effective analgesia. However, there remains limited knowledge of the analgesic efficacy and clinical utility of adding dexmedetomidine to articaine during peripheral nerve block in humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18-60 years planned for upper limb surgery below the midhumerus with an expected time of less than 90 min usually under tourniquet.\n\nExclusion Criteria:\n\n* allergies to local anesthetic,\n* those with ASA III and IV,\n* patients who refuse to participate,\n* uncooperative patients,\n* patients who have infection at the site of injection,\n* patients who have bleeding disorder, and patients on anticoagulant drugs.'}, 'identificationModule': {'nctId': 'NCT06423859', 'briefTitle': 'Articaine Plus Dexmedetomidine in Supraclavicular Block', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'A Comparative Study Between Articaine Alone Versus Articaine Plus Dexmedetomidine for Ambulatory Orthopedic Surgery Under Supraclavicular Block', 'orgStudyIdInfo': {'id': 'RC 19-1-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Articaine alone', 'description': 'supraclavicular brachial plexus block will be performed in this group guided by ultrasound. A 30 ml volume local anesthetic will be injected in the form of (29 cc articaine 2% + 1 cc isotonic saline)', 'interventionNames': ['Drug: Articaine']}, {'type': 'EXPERIMENTAL', 'label': 'Articaine and Dexmedetomidine', 'description': 'supraclavicular brachial plexus block will be performed in this group guided by ultrasound. A 30 ml volume local anesthetic will be injected in the form of (29 cc articaine 2% + 1 cc volume of Dexmedetomidine 1 ug/kg)', 'interventionNames': ['Drug: Articaine', 'Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Articaine', 'type': 'DRUG', 'description': 'supraclavicular brachial plexus block with articaine 2%', 'armGroupLabels': ['Articaine alone', 'Articaine and Dexmedetomidine']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'supraclavicular brachial plexus block with articaine 2% in addition with Dexmedetomidine', 'armGroupLabels': ['Articaine and Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'Qalyubia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Samar R. Amin, lecturer', 'role': 'CONTACT', 'email': 'samar.rafik@gmail.com', 'phone': '01287793991'}], 'facility': 'Samar Rafik Mohamed Amin', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'centralContacts': [{'name': 'Samar R Amin, MD', 'role': 'CONTACT', 'email': 'samar.rafik@gmail.com', 'phone': '+201287793991'}, {'name': 'Elsayed M abdelzaam, MD', 'role': 'CONTACT', 'email': 'sayedzim12@yahoo.com', 'phone': '0133227518'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of anaesthesia and intensive care', 'investigatorFullName': 'Samar Rafik Mohamed Amin', 'investigatorAffiliation': 'Benha University'}}}}