Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-30 @ 4:09 PM
Study NCT ID:
NCT04420104
Status:
UNKNOWN
Last Update Posted:
2020-07-08
First Post:
2020-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000698', 'term': 'Analgesia'}], 'ancestors': [{'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from baseline in pain the 10 point Visual Analog Scale (VAS) at hours 3,6,9,12,24,36,48.', 'timeFrame': 'baseline and hours 3-6-12-24-36-48', 'description': 'The VAS is validated instrument assessing average pain. Possible scores range from 0 (no pain) to 10 (worst possible pain) Change= (hours 3,6,9,12,24,48 score- baseline)'}, {'measure': 'time to mobilize the patient', 'timeFrame': 'Any time for 7 days', 'description': 'time to mobilize the patient is reported as when the patient is mobilized'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erector Spinae Plane Block', 'Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '30052229', 'type': 'BACKGROUND', 'citation': 'Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.'}, {'pmid': '30055991', 'type': 'BACKGROUND', 'citation': 'Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess efficacy of erector spinae plane block (ESP) for postoperative pain management in cardiac surgery patients.', 'detailedDescription': 'After being informed about the study and potential risks, all patients giving written informed consent will be randomised (single blind) as block group(patients is performed esp block) and control group. All patients will be evaluate during 48 hours for postoperative pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be ASA score I-III\n* Must be 18-75 years old\n* must undergo cardiac surgery\n\nExclusion Criteria:\n\n* emergency surgery,\n* bleeding diathesis,\n* presence of contraindications to LA agents used in this study,\n* use of chronic opioids,\n* psychiatric disorders.\n* prolonged extubation\n* presence of infection at the injection site.\n* cardiovascular conditions (EF\\<40, LMCA obstruction)'}, 'identificationModule': {'nctId': 'NCT04420104', 'briefTitle': 'Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AMU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'esp block group', 'interventionNames': ['Procedure: erector spinae plane block', 'Drug: iv analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'interventionNames': ['Drug: iv analgesia']}], 'interventions': [{'name': 'erector spinae plane block', 'type': 'PROCEDURE', 'description': 'ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.', 'armGroupLabels': ['esp block group']}, {'name': 'iv analgesia', 'type': 'DRUG', 'description': 'iv contromal', 'armGroupLabels': ['control group', 'esp block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09100', 'city': 'Aydin', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'sinem sari', 'role': 'CONTACT', 'email': 'sarisinem@yahoo.com', 'phone': '090 4441256-2108'}, {'name': 'Pelin Dilsiz', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nil Kaan', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Erdem Ali Ozkisacik', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tunay Kurtoglu', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Varlik Erel', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}], 'centralContacts': [{'name': 'Sinem Sari, Assoc Prof', 'role': 'CONTACT', 'email': 'sarisinem@yahoo.com', 'phone': '90 507 539 63 13'}], 'overallOfficials': [{'name': 'Sinem Sari, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adnan Menderes University Medical Faculty Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Dr.', 'investigatorFullName': 'SINEM SARI', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}