Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT05983393
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2023-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erector Spina Plane Block for Multilevel Major Spinal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-06', 'studyFirstSubmitDate': '2023-08-01', 'studyFirstSubmitQcDate': '2023-08-01', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'opioid consumption', 'timeFrame': 'up to 24 hour', 'description': 'The amount of morphine consumed in milligrams in the first 24 hours was determined with a patient-controlled analgesia pump.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain', 'postoperative analgesia', 'Erector spinae plane block', 'posterior spinal instrumentation'], 'conditions': ['Pain', 'Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic analgesic activity at paraspinal muscles. This study aims to examine the postoperative analgesic efficacy of ESP block in patients undergoing posterior spinal instrumentation', 'detailedDescription': 'Postoperative patient-controlled analgesia in the ESP group and control group will be compared with 24-hour morphine consumption and NRS scores at different time points. In addition, the need for rescue analgesics and patient satisfaction will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III patients\n* Agreed to participate in the study\n\nExclusion Criteria:\n\n* Patients with infection at the injection site\n* Coagulopathy Allergy to amide-type local anesthetics\n* History of peripheral neuropathy\n* Hepatic and/or renal failure\n* Refusing the procedure\n* Patients with heart disease\n* Patients who have previously undergone surgery from the same area'}, 'identificationModule': {'nctId': 'NCT05983393', 'briefTitle': 'Erector Spina Plane Block for Multilevel Major Spinal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'Effect of Ultrasound-guided Bilateral Erector Spina Plan Block for Postoperative Analgesia in Patients Undergoing Multilevel Posterior Spinal Instrumentation.', 'orgStudyIdInfo': {'id': '2020/12-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'No block was performed', 'interventionNames': ['Procedure: Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erector spinae plane block', 'description': 'Erector spinae plane block was performed, morphine was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.', 'interventionNames': ['Procedure: Erector spinae plane block']}], 'interventions': [{'name': 'Erector spinae plane block', 'type': 'PROCEDURE', 'description': 'Erector spinae plane block was performed', 'armGroupLabels': ['Erector spinae plane block']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'Erector spinae plane block was not applied.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46100', 'city': 'Kahramanmaraş', 'country': 'Turkey (Türkiye)', 'facility': 'Kahramanmaras Sutcu Imam University Hospital', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}], 'overallOfficials': [{'name': 'Gökce Gişi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kahramanmaras Sutcu Imam Universty'}, {'name': 'Gözen Öksüz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kahramanmaras Sutcu Imam Universty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gökçe Gişi', 'investigatorAffiliation': 'Kahramanmaras Sutcu Imam University'}}}}