Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT05282303
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2022-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REGIONAL ANALGESIA TECHNIQUES FOR EFFECTIVE RECOVERY TO CORONARY ARTERY BYPASS SURGERIES: A RETROSPECTİVE STUDY IN A SINGLE CENTER EXPERIENCE
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2022-02-25', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative analgesia', 'timeFrame': '0 - 24 hours', 'description': 'NRS score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '25500688', 'type': 'RESULT', 'citation': 'Bigeleisen PE, Goehner N. Novel approaches in pain management in cardiac surgery. Curr Opin Anaesthesiol. 2015 Feb;28(1):89-94. doi: 10.1097/ACO.0000000000000147.'}, {'pmid': '23273101', 'type': 'RESULT', 'citation': 'Doehring A, Oertel BG, Sittl R, Lotsch J. Chronic opioid use is associated with increased DNA methylation correlating with increased clinical pain. Pain. 2013 Jan;154(1):15-23. doi: 10.1016/j.pain.2012.06.011.'}, {'pmid': '30052229', 'type': 'RESULT', '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': '31054241', 'type': 'RESULT', 'citation': 'Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.'}, {'pmid': '29561295', 'type': 'RESULT', 'citation': 'Elsharkawy H, Pawa A, Mariano ER. Interfascial Plane Blocks: Back to Basics. Reg Anesth Pain Med. 2018 May;43(4):341-346. doi: 10.1097/AAP.0000000000000750.'}]}, 'descriptionModule': {'briefSummary': 'Background Pain after cardiac surgery is both multifocal and multifactorial. Sternotomy, sternal retraction, internal mammary dissection, posterior rib dislocation or fracture, possible brachial plexus injury, and mediastinal and pleural drains contribute to pain experienced in the immediate postoperative period. Ineffective pain management can cause systemic and pulmonary complications and significant cardiac consequences.\n\nMethods This study was conducted to compare the effectiveness of regional anesthesia techniques for perioperative pain management in cardiac surgery patients at our clinic. The effects of analgesic methods, in terms of contributing to recovery, have been examined.', 'detailedDescription': 'This study was approved by the Koç University Clinical Research Ethics Committee (2021.464.IRB1.131); patients who underwent coronary artery bypass grafting (CABG) surgery at the VKV American Hospital between January 2015 and May 2020 were reviewed retrospectively. Patients with a history of cerebrovascular events, scheduled carotid surgery, or emergency CABG surgery were excluded from the study. Demographic data from the preoperative evaluation forms and operation types from the surgery reports were recorded. Intraoperative anesthesia follow-up forms were assessed if regional anesthesia was used, and the type and extent of opioids during the operation were examined. The postoperative transfer forms were examined to the cardiovascular intensive care unit (CICU), intensive care follow-up forms, and service ward record follow-up forms. Pain scores (NRS) during rest and coughing, vital signs, mobilization, and the start of respiratory exercises were recorded for postoperative respiratory complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery disease scheduled for bypass surgery', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Who underwent coronary artery bypass grafting (CABG) surgery at the VKV American Hospital between January 2015 and May 2020 were reviewed retrospectively\n\nExclusion Criteria:\n\n* History of cerebrovascular event\n* History of Alzheimer's and dementia\n* Inadequate cognitive functions\n* History of chronic pain\n* Long-term opioid therapy"}, 'identificationModule': {'nctId': 'NCT05282303', 'briefTitle': 'REGIONAL ANALGESIA TECHNIQUES FOR EFFECTIVE RECOVERY TO CORONARY ARTERY BYPASS SURGERIES: A RETROSPECTİVE STUDY IN A SINGLE CENTER EXPERIENCE', 'organization': {'class': 'OTHER', 'fullName': 'V.K.V. American Hospital, Istanbul'}, 'officialTitle': 'REGIONAL ANALGESIA TECHNIQUES FOR EFFECTIVE RECOVERY TO CORONARY ARTERY BYPASS SURGERIES: A RETROSPECTİVE STUDY IN A SINGLE CENTER EXPERIENCE', 'orgStudyIdInfo': {'id': 'Cosarcan3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DIESPB', 'description': 'Dual injection of erector spinae plane block', 'interventionNames': ['Procedure: CABG operation']}, {'label': 'TPVB', 'description': 'Thoracic paravertebral block', 'interventionNames': ['Procedure: CABG operation']}, {'label': 'SAB', 'description': 'Serratus anterior plane block', 'interventionNames': ['Procedure: CABG operation']}, {'label': 'PIB', 'description': 'Parasternal ıntercostal block', 'interventionNames': ['Procedure: CABG operation']}], 'interventions': [{'name': 'CABG operation', 'type': 'PROCEDURE', 'description': 'Efficacy of regional analgesia techniques in coronary artery bypass operations', 'armGroupLabels': ['DIESPB', 'PIB', 'SAB', 'TPVB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34365', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'American Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'V.K.V. American Hospital, Istanbul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sami Kaan Coşarcan', 'investigatorAffiliation': 'V.K.V. American Hospital, Istanbul'}}}}