Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT06658418
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-26
First Post:
2024-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Block with Dexmedetomidine and Bupivacain Versus Dexamethasone and Bupivacain for Postoperative Analgesia in Patients Undergoing Abdominal Surgeries
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2024-10-24', 'studyFirstSubmitQcDate': '2024-10-24', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS score', 'timeFrame': 'at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperative.', 'description': 'pain intensity using VAS score'}], 'secondaryOutcomes': [{'measure': 'the time for requirement of first morphine dose', 'timeFrame': 'at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperative.', 'description': 'the time for requirement of first morphine dose (hours)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia, Postoperative']}, 'referencesModule': {'references': [{'pmid': '20418538', 'type': 'BACKGROUND', 'citation': 'Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.'}]}, 'descriptionModule': {'briefSummary': 'To compare the analgesic effect of dexmedetomidine combined with bupivacaine versus dexamethasone combined with bupivacaine for ultrasound-guided ESPB for postoperative pain control in patients scheduled for abdominal surgeries'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge :18 years old and older. Patients undergoing open abdominal surgery.\n\nExclusion Criteria:\n\n1. Patient refusal\n2. known sensitivity or contraindication to any of study drugs\n3. contraindications for local anesthesia\n4. Patients with local infection at site of puncture\n5. uncooperative patients\n6. history of psychological disorders or chronic pain and significant liver or renal disease.'}, 'identificationModule': {'nctId': 'NCT06658418', 'briefTitle': 'Erector Spinae Plane Block with Dexmedetomidine and Bupivacain Versus Dexamethasone and Bupivacain for Postoperative Analgesia in Patients Undergoing Abdominal Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Erector Spinae Plane Block with Dexmedetomidine and Bupivacain Versus Dexamethasone and Bupivacain for Postoperative Analgesia in Patients Undergoing Abdominal Surgeries', 'orgStudyIdInfo': {'id': 'erector spinae plane block'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine combined with bupivacaine', 'description': 'use for Dexmedetomidine and bupivacain for erector spinae plane block', 'interventionNames': ['Procedure: Erector Spinae Plane Block']}, {'type': 'EXPERIMENTAL', 'label': 'dexamethasone combined with bupivacaine', 'description': 'use of dexamethasone combined with bupivacaine for erector spinae plane block', 'interventionNames': ['Procedure: Erector Spinae Plane Block']}], 'interventions': [{'name': 'Erector Spinae Plane Block', 'type': 'PROCEDURE', 'description': 'dexmedetomidine combined with bupivacaine versus dexamethasone combined with bupivacaine for ultrasound-guided ESPB for postoperative pain control in patients scheduled for abdominal surgeries.', 'armGroupLabels': ['dexamethasone combined with bupivacaine', 'dexmedetomidine combined with bupivacaine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'loay GAMAL loay Gamal, master', 'role': 'CONTACT', 'email': 'loaygamal94@gmail.com', 'phone': '+201017675686'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loay Gamal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'LGamal', 'investigatorFullName': 'Loay Gamal', 'investigatorAffiliation': 'Assiut University'}}}}