Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 5:54 PM
Study NCT ID:
NCT04447560
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2020-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Erector Spinae Plane Block Method Used in Pain Management in Heart Surgery on Vascular Diameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-12', 'size': 61539, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-06-13T14:32', 'hasProtocol': True}, {'date': '2020-06-12', 'size': 260624, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-06-13T14:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study is planned as prospective. Aged between 18-75, ASA III risk group and are undergoing off pump coronary artery bypass grafting surgery are selected for the study. Who are allergic to planned-medications, chronic opioid or opioid receptor agonist users, those with preoperative neuropathies, psychiatric diseases will be excluded. Electrocardiography and pulse oximetry monitorization is performed in the recovery room where a peripheric intravenous line is opened afterwards. High frequency (12-24 MHz) linear probe is used for measurements. Images will be recorded by USG from the 3., 4. and 5. intercostal spaces for the LIMA and RIMA and 3cm proximal to the wrist for the right and left radial arteries. After images are saved, the researcher will perform ESP block with USG. ESP block will be performed to right and left sides equally with 40ml %0.25 bupivacaine in total. Artery images will be recorded again by the same researcher after 45 minutes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2020-06-01', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of erector spinae plane (ESP) block on the change in diameters of mammarian arteries and radial arteries', 'timeFrame': 'The first measurement will be done in the pre-operative preparation room for each participant, and block will be performed in sitting position by an experienced anesthesiologist. Second measurement will be done 45 minutes after performing the ESP block', 'description': 'Linear probe is used for measurements. Images will be recorded by ultrasound from the third, fourth and fifth intercostal spaces for the LIMA and RIMA and 3cm proximal to the wrist for the right and left radial arteries. After images are saved, the researcher will perform ESP block with USG. Linear/convex probe is used to place the needle parasagittally 3 cm lateral to T5 spinous processes. ESP block will be performed to right and left sides equally with 40ml %0.25 bupivacaine in total, to the fascial plane between the transverse process and erector spinae muscle. Artery images will be recorded again by the same researcher after 45 minutes.For the recordings, one researcher will record the images as explained in the protocol and two researchers will measure the records separately. The results measured in millimeters by two researchers will be compared statistically and if there is no significant difference, the average value of the records will be used for statistical analysis.'}], 'secondaryOutcomes': [{'measure': 'Measurement of Mean Arterial Pressure on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block', 'timeFrame': 'The first measurement will be done in the pre-operative preparation room for each participant, and block will be performed. After the block, a measurement will be made every 5 minutes. The last measurement will be made 45 minutes after the block.', 'description': 'When each participant comes to the preoperative preparation room, the mean arterial pressure will be measured in mmHg. Then the erector spinae plane block will be performed. After the block is performed, a measurement will be recorded every 5 minutes. The last measurement will be done 45 minutes after the block is performed.'}, {'measure': 'Measurement of Mean Heart Rate on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block.', 'timeFrame': 'The first measurement will be done in the pre-operative preparation room for each participant, and block will be performed. After the block, a measurement will be made every 5 minutes. The last measurement will be made 45 minutes after the block.', 'description': 'When each participant comes to the preoperative preparation room, the heart rate will be measured in per minute. Then the erector spinae plane block will be performed. After the block is performed, a measurement will be recorded every 5 minutes. The last measurement will be done 45 minutes after the block is performed.'}, {'measure': 'Measurement of Pulse Oxymetri on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block.', 'timeFrame': 'The first measurement will be done in the pre-operative preparation room for each participant, and block will be performed. After the block, a measurement will be made every 5 minutes. The last measurement will be made 45 minutes after the block.', 'description': 'When each participant comes to the preoperative preparation room, the pulse oximetry will be measured. Then the erector spinae plane block will be performed. After the block is performed, a measurement will be recorded every 5 minutes. The last measurement will be done 45 minutes after the block is performed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac anesthesia', 'Sympathectomy', 'Off-pump coroner artery by-pass surgery'], 'conditions': ['Coronary Artery Disease', 'Erector Spinae Plane Block', 'Bypass Extremity Graft']}, 'referencesModule': {'references': [{'pmid': '16534283', 'type': 'BACKGROUND', 'citation': 'Alvarez J, Hernandez B, Atanassoff PG. High thoracic epidural anesthesia and coronary artery disease in surgical and non-surgical patients. Curr Opin Anaesthesiol. 2005 Oct;18(5):501-6. doi: 10.1097/01.aco.0000183104.73931.22.'}, {'pmid': '20479150', 'type': 'BACKGROUND', 'citation': 'Bourke T, Vaseghi M, Michowitz Y, Sankhla V, Shah M, Swapna N, Boyle NG, Mahajan A, Narasimhan C, Lokhandwala Y, Shivkumar K. Neuraxial modulation for refractory ventricular arrhythmias: value of thoracic epidural anesthesia and surgical left cardiac sympathetic denervation. Circulation. 2010 Jun 1;121(21):2255-62. doi: 10.1161/CIRCULATIONAHA.109.929703. Epub 2010 May 17.'}, {'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.'}, {'pmid': '31833864', 'type': 'BACKGROUND', 'citation': "Smith LM, Barrington MJ; St Vincent's Hospital, Melbourne. Ultrasound-guided blocks for cardiovascular surgery: which block for which patient? Curr Opin Anaesthesiol. 2020 Feb;33(1):64-70. doi: 10.1097/ACO.0000000000000818."}, {'pmid': '30676423', 'type': 'RESULT', 'citation': 'Wink J, Veering BT, Aarts LPHJ, Wouters PF. Effects of Thoracic Epidural Anesthesia on Neuronal Cardiac Regulation and Cardiac Function. Anesthesiology. 2019 Mar;130(3):472-491. doi: 10.1097/ALN.0000000000002558.'}]}, 'descriptionModule': {'briefSummary': 'Off-pump coronary artery bypass grafting (OPCABG) is a bypass method performed on the working heart. Pain is a frequently seen side effect experienced following this surgery. Erector spinae plane block is our analgesia method that the investigators routinely perform prior to the surgery to overcome this problem. In this method, analgesic medication is given via a needle in between the two superficial muscle groups (erector spinae muscles) located in participants back. The investigators believe this method not only provides pain relief, but also is beneficial (dilating) on the vessels that will be used for bypassing the clogged vessels during the surgery. The investigators aimed to measure some parameters in this routine procedure before and after performing the analgesic method with an ultrasound (imaging with sound waves).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are aged between 18-75,\n* ASA III\n* Patients who are undergoing off pump coronary artery bypass grafting surgery\n\nExclusion Criteria:\n\n* Patients who are allergic to planned-medications,\n* those with previous cardiac surgery,\n* patients undergoing emergency surgery,\n* uncontrolled diabetes mellitus,\n* chronic opioid or opioid receptor agonist users,\n* those with pre-operative neuropathies, psychiatric diseases,\n* non-communicable patients and\n* those who refuse to participate'}, 'identificationModule': {'nctId': 'NCT04447560', 'briefTitle': 'Effects of Erector Spinae Plane Block Method Used in Pain Management in Heart Surgery on Vascular Diameters', 'organization': {'class': 'OTHER', 'fullName': 'Koç University'}, 'officialTitle': 'Effects of Erector Spinae Plane Block on Sympathectomy in Off Pump Coronary Artery Bypass Surgery', 'orgStudyIdInfo': {'id': 'ESPCVS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erector Spinae Plane Block', 'description': 'One researcher will record the artery images as explained in the protocol before and after the plane block and two researchers will measure the radius and area of those vessels separately.', 'interventionNames': ['Procedure: Erector Spinae Plane Block']}], 'interventions': [{'name': 'Erector Spinae Plane Block', 'type': 'PROCEDURE', 'otherNames': ['Bupivacaine'], 'description': "One researcher will record the artery images as explained in the protocol and two researchers will measure the radius and area of those vessels separately. Researchers who are measuring the radius and area of vessels won't know whether those images belong to pre or post- ESP block. The results two researchers measure will be compared statistically and if there are no statistically significant differences, the mean value of their separate recordings will be taken into account for the statistical analysis.", 'armGroupLabels': ['Erector Spinae Plane Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34010', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Koc University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Ömür Erçelen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Koç University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Starting from 6 months after publication for 5 years', 'ipdSharing': 'YES', 'accessCriteria': 'No access criteria'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Koç University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Kamil Darcin', 'investigatorAffiliation': 'Koç University'}}}}