Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-01-27 @ 5:11 AM
Study NCT ID:
NCT03632161
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2018-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Para-vertebral Dexmedetomidine and the Incidence of Postoperative Chronic Pain
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': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-19', 'studyFirstSubmitDate': '2018-08-09', 'studyFirstSubmitQcDate': '2018-08-14', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'acute postoperative pain', 'timeFrame': '24 hours', 'description': 'assessment of pain by visual analog scale (VAS) by cm with minimal =0 and maximal =10, worst pain mean scale of 10'}], 'secondaryOutcomes': [{'measure': 'chronic post thoracic surgery pain', 'timeFrame': '3 months', 'description': 'Chronic neuropathic pain was assessed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale with non-neuropathic pain if the scale \\<12, and neuropathic pain is likely to be the contributing cause of pain if the scale \\>12'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '31151335', 'type': 'DERIVED', 'citation': 'Abd-Elshafy SK, Abdallal F, Kamel EZ, Edwar H, Allah EA, Maghraby HHM, Sayed JA, Ali MS, Elkhayat H, Mahran GSK. Paravertebral Dexmedetomidine in Video-Assisted Thoracic Surgeries for Acute and Chronic Pain Prevention. Pain Physician. 2019 May;22(3):271-280.'}]}, 'descriptionModule': {'briefSummary': 'Up to our knowledge there is no study focused upon the incidence of post VATS chronic pain when dexmedetomidine is used.', 'detailedDescription': 'Most Video-Assisted Throcoscopy Surgery (VATS) procedures are considered low-risk interventions requiring short hospital stays or even outpatient settings. Because of these factors, VATS did not raise as much interest as thoracotomy in its postoperative pain management. However, it is a fact that pain following VATS can be severe and long-lasting .According to Richardson and colleagues, 38% of VATS procedures present persistent pain two months after surgery as a result of acute nerve damage during the surgical procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA II-III\n* Adult\n* Video-assisted thoracic surgery\n\nExclusion Criteria:\n\n* Patient refusal\n* Allergy to medication\n* Coagulopathy\n* Malformation'}, 'identificationModule': {'nctId': 'NCT03632161', 'briefTitle': 'Para-vertebral Dexmedetomidine and the Incidence of Postoperative Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Para-Vertebral Dexmedetomidine in Video-Assisted Thoracic Surgeries for Acute and Chronic Pain Prevention; A Randomized Double Blinded Clinical Trial', 'orgStudyIdInfo': {'id': 'IRB00009920'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': 'Dexmedetomidine is added to bupivacaine the paravertebral block', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'OTHER', 'label': 'Bupivacaine', 'description': 'Bupivacaine only in the paravertebral block', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'isobaric bupivacaine 0.5% (0.3ml/kg) and dexmedetomidine (1 mcg/kg)', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'isobaric bupivacaine 0.5% (0.3ml/kg)', 'armGroupLabels': ['Bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Emad Zarief Kamel Said', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Emad Zarief , MD', 'investigatorAffiliation': 'Assiut University'}}}}