Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-02-20 @ 5:58 PM
Study NCT ID:
NCT03121261
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-06
First Post:
2017-04-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}, {'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2017-04-11', 'studyFirstSubmitQcDate': '2017-04-19', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '4 Item Duration of Latency and duration of the cutaneous silent period', 'timeFrame': '24 hours perioperative', 'description': 'Duration of latency and duration of the cutaneous silent (msec) period before subarahnoid block, after regression of motor block, sixth hour of intrathecal administration, 24 hours after intrathecal administration'}], 'secondaryOutcomes': [{'measure': 'Duration of motor block', 'timeFrame': '24 hours perioperative', 'description': 'The duration of motor block and its regression will be monitored by Bromage scale:0- Bromage patient can perform movements in the hip, knee and foot. Bromage 1-patient can not perform movements in the hip, but can flexes the knee and move the foot, Bromage 2- patient can not perform movements in the hip and knee, but can move a foot. Bromage 3- patient can not perform movements in the hip, knee nor move the foot. The time of intrathecal levobupivacaine solution or levobupivacaine and clonidine solution is considered to be time zero.'}, {'measure': 'Duration of sensory block', 'timeFrame': '24 hours perioperative', 'description': 'The time needed for the regression of sensory block in two dermatome will be measured; the time (min) required for a regression in the S1 dermatome, the time required to restore motor functions in Bromage 0 and the duration of analgesia(min).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['levobupivacaine', 'nerve fibers', 'clonidine'], 'conditions': ['Inguinal Hernia', 'Spinal Anesthesia']}, 'referencesModule': {'references': [{'pmid': '9152203', 'type': 'BACKGROUND', 'citation': 'Inghilleri M, Cruccu G, Argenta M, Polidori L, Manfredi M. Silent period in upper limb muscles after noxious cutaneous stimulation in man. Electroencephalogr Clin Neurophysiol. 1997 Apr;105(2):109-15. doi: 10.1016/s0924-980x(97)96579-6.'}, {'pmid': '26025613', 'type': 'BACKGROUND', 'citation': 'Mota IA, Fernandes JB, Cardoso MN, Sala-Blanch X, Kofler M, Valls-Sole J. Temporal profile of the effects of regional anesthesia on the cutaneous reflexes of foot muscles. Exp Brain Res. 2015 Sep;233(9):2587-96. doi: 10.1007/s00221-015-4329-2. Epub 2015 May 30.'}, {'pmid': '1718720', 'type': 'RESULT', 'citation': 'Uncini A, Kujirai T, Gluck B, Pullman S. Silent period induced by cutaneous stimulation. Electroencephalogr Clin Neurophysiol. 1991 Oct;81(5):344-52. doi: 10.1016/0168-5597(91)90023-q.'}]}, 'descriptionModule': {'briefSummary': 'The cutaneous silent period is a non-invasive technique that gives insight into the function of thin A delta fibers and as such can be a complement to conventional electrophysiological methods used to study the peripheral nerves. Clonidine is a selective partial agonist of the alpha-2 receptors which, added intrathecally to levobupivacaine, enhances the effect of a local anesthetic, prolongs sensory and motor block during local anesthesia and extends the length of post-operative analgesia. It is believed that clonidine achieves this effect by activating the postsynaptic alpha-2 receptors in the gelatine substance of the spinal cord and blocking the conduction of A-delta and C fibers. The aim of the study is to examine functional changes of Aδ - fibers during the application of spinal anesthesia by measuring the cutaneous slinet period and compare the effect of intrathecal administration of a combination of local anesthetic and clonidine in the quiet skin period in relation to the application of local anesthetic only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nASA one and two status BMI 18,5 to 24\n\nExclusion Criteria:\n\nCoagulation disorders Polyneuropathy Diabetes mellitus Alcoholism Systemic inflammatory and malignant diseases Stroke'}, 'identificationModule': {'nctId': 'NCT03121261', 'briefTitle': 'The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Dubrava'}, 'officialTitle': 'The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During and After Spinal Anesthesia', 'orgStudyIdInfo': {'id': '070219812014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.5% levobupivacaine with 0.015% clonidine', 'description': '0.5% levobupivacaine 15 mg with 0.015% clonidine 50 mcg and 40% glucose 0.5 ml will be preformed as subarachnoid block', 'interventionNames': ['Drug: levobupivacaine', 'Drug: clonidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.5% levobupivacaine with 0.9% saline', 'description': '0.5% levobupivacaine 15 mg with 0.33 ml of 0.9% saline and 40% glucose 0.5 ml will be preformed as subarachnoid block', 'interventionNames': ['Drug: levobupivacaine', 'Drug: clonidine']}], 'interventions': [{'name': 'levobupivacaine', 'type': 'DRUG', 'otherNames': ['chirocaine'], 'description': 'Comparing: 0.5% levobupivacaine 15 milligrams (mg) , 0.015% clonidine 50 micrograms (mcg) and 40% glucose 0.5 milliliters (ml) with 0.5 levobupivacaine 15 mg , 0.9% saline 0.33 ml and 40% glucose 0.5 ml', 'armGroupLabels': ['0.5% levobupivacaine with 0.015% clonidine', '0.5% levobupivacaine with 0.9% saline']}, {'name': 'clonidine', 'type': 'DRUG', 'otherNames': ['catapressan'], 'description': 'Comparing: 0.5% levobupivacaine 15 mg , 0.015% clonidine 50 mcg and 40% glucose 0.5 ml with 0.5 levobupivacaine 15 mg , 0.9% saline 0.33 ml and 40% glucose 0.5 ml', 'armGroupLabels': ['0.5% levobupivacaine with 0.015% clonidine', '0.5% levobupivacaine with 0.9% saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Clinical Hospital Dubrava', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Dubrava', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurology Specialist', 'investigatorFullName': 'Sandra Graf Zupcic', 'investigatorAffiliation': 'University Hospital Dubrava'}}}}