Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-05 @ 6:08 PM
Study NCT ID:
NCT05851768
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Dexmedetomidine VS Magnesium Sulphate With Bupivacaine in Erector Spinae Block for Thoracotomy Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D008274', 'term': 'Magnesium'}, {'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': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-04-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-18', 'studyFirstSubmitDate': '2023-05-01', 'studyFirstSubmitQcDate': '2023-05-01', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total postoperative morphine consumption', 'timeFrame': 'First 24 hours postoperatively', 'description': 'Total dose of morphine needed postoperatively in the first 24 h'}], 'secondaryOutcomes': [{'measure': 'Time to first postoperative rescue analgesia.', 'timeFrame': 'First 24 hours postoperatively', 'description': 'Time to first postoperative rescue analgesia.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': 'Postoperative pain management is considered an integral part of perioperative care in patients undergoing thoracotomy. In order to reduce these complications, multiple regional techniques have been developed for thoracotomy including Intercostal nerve block, Erectospinae plane block and serratus block. Multiple adjuvants have been used in regional analgesia including adrenaline,clonidine,magnesium sulphate,dexmedatomidine and opoids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 65 years.\n* Male and female sexes.\n* ASA I-II.,III\n* Cancer patients undergoing thoracotomy incisions\n* Body mass index (BMI) from 18.5 to 30 kg/m2\n\nExclusion Criteria:\n\n* Patient refusal\n* Known allergy to any of the used drugs\n* Low platelet count, any coagulation defect'}, 'identificationModule': {'nctId': 'NCT05851768', 'briefTitle': 'Efficacy of Dexmedetomidine VS Magnesium Sulphate With Bupivacaine in Erector Spinae Block for Thoracotomy Pain', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Analgesic Efficacy of Adding Dexmedetomidine VS Magnesium Sulphate as Adjuvants With Bupivacaine in Ultrasound-guided Erector Spinae Plane Block for Post Thoracotomy Pain', 'orgStudyIdInfo': {'id': 'N-80-2022/NSC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Erector spinae plane block with 0.25% bupivacaine', 'description': 'Patients will receive ultrasound guided ESPB with 0.25% bupivacaine', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Erector spinae plane block with 0.25% bupivacaine and Magnesium', 'description': 'Patients will receive ultrasound guided ESPB with 0.25% bupivacaine and magnesium', 'interventionNames': ['Drug: Bupivacaine + Magnesium']}, {'type': 'EXPERIMENTAL', 'label': 'Erector spinae plane block with 0.25% bupivacaine and Dexmedetomidine', 'description': 'Patients will receive ultrasound guided ESPB with 0.25% bupivacaine and dexmedetomidine', 'interventionNames': ['Drug: Bupivacaine + Dexmedetomidine']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'Bupivacaine 0.25%', 'armGroupLabels': ['Erector spinae plane block with 0.25% bupivacaine']}, {'name': 'Bupivacaine + Magnesium', 'type': 'DRUG', 'description': 'Bupivacaine 0.25% + Magnesium', 'armGroupLabels': ['Erector spinae plane block with 0.25% bupivacaine and Magnesium']}, {'name': 'Bupivacaine + Dexmedetomidine', 'type': 'DRUG', 'description': 'Bupivacaine 0.25% + Dexmedetomidine', 'armGroupLabels': ['Erector spinae plane block with 0.25% bupivacaine and Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Walaa Y Elsabeeny, MD', 'role': 'CONTACT', 'email': 'walaa.elsabeeny@nci.cu.edu.eg', 'phone': '+201007798466'}], 'facility': 'Walaa Y Elsabeeny', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Walaa Y Elsabeeny, MD', 'role': 'CONTACT', 'email': 'walaa.elsabeeny@nci.cu.edu.eg', 'phone': '01007798466', 'phoneExt': '+2'}, {'name': 'Ahmed A Mohamed, MD', 'role': 'CONTACT', 'email': 'ahmed.aboali7268@gmail.com', 'phone': '01272222923', 'phoneExt': '+2'}], 'overallOfficials': [{'name': 'Walaa Y Elsabeeny, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University'}, {'name': 'Ahmed A Mohamed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of Anesthesia,Surgical intensive care and Pain management,Faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Information is available upon reasonable request through contacting the corresponding investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Anesthesia and Pain management', 'investigatorFullName': 'Walaa Youssef Elsabeeny', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}