Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-02-23 @ 9:33 AM
Study NCT ID:
NCT02544893
Status:
COMPLETED
Last Update Posted:
2016-08-03
First Post:
2015-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Analgesic Effects of Using Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2015-09-07', 'studyFirstSubmitQcDate': '2015-09-07', 'lastUpdatePostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'opioid consumption', 'timeFrame': 'postoperative 24 hours', 'description': 'patient controlled analgesia'}], 'secondaryOutcomes': [{'measure': 'visual analog scale', 'timeFrame': 'postoperative 1 day', 'description': 'visual analog scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'we aimed postoperative analgesic effects of using bupivacaine alone or added dexmedetomidine for ultrasound guided thoracic paravertebral block in thoracotomy', 'detailedDescription': 'paravertebral block is commonly used in the treatment for acute and chronic pain.The duration of paravertebral block could theoretically be prolonged with neurolytic agents. Dexmedetomidine ,an alfa-2 adrenoreceptor agonist, is being used and adjuvant capable of prolonging duration of sensory and motor block on nerve blocks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1-2\n* 18-65 aged\n* patient undergoing thoracotomy\n\nExclusion Criteria:\n\n* chronic opioid consumption\n* bupivacaine and dexmedetomidine allergies\n* coagulopathy\n* infection at the needle insertion side\n* chronic liver and kidney disease'}, 'identificationModule': {'nctId': 'NCT02544893', 'briefTitle': 'Postoperative Analgesic Effects of Using Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Postoperative Analgesic Effects of Using Bupivacaine Alone or Added Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block in Thoracotomy', 'orgStudyIdInfo': {'id': '2014/649'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine', 'description': '0,5% 20 ml bupivacaine added 0.9% 1 ml serum physiologic on paravertebral block', 'interventionNames': ['Drug: bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine', 'description': '100 mcg dexmedetomidine added to 0,5% 20 ml bupivacaine on paravertebral block', 'interventionNames': ['Drug: dexmedetomidin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'serum phsyologic', 'description': '0,9% 21 ml serum physiologic', 'interventionNames': ['Drug: serum physiologic']}], 'interventions': [{'name': 'bupivacaine', 'type': 'DRUG', 'otherNames': ['marcaine'], 'description': '21 ml 0.5 %bupivacaine is applied paravertebral space', 'armGroupLabels': ['bupivacaine']}, {'name': 'dexmedetomidin', 'type': 'DRUG', 'otherNames': ['precedex'], 'description': '1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied paravertebral space', 'armGroupLabels': ['dexmedetomidine']}, {'name': 'serum physiologic', 'type': 'DRUG', 'description': '21 ml serum physiologic is applied paravertebral space', 'armGroupLabels': ['serum phsyologic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38080', 'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University Medicine Faculty', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'esra n ünalan, resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TC Erciyes University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident', 'investigatorFullName': 'Esra Nur Ünalan', 'investigatorAffiliation': 'TC Erciyes University'}}}}