Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT05476393
Status:
WITHDRAWN
Last Update Posted:
2023-07-27
First Post:
2022-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ESPB vs TPVB for Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two models for this study. The first group is erector spinae plane block group. The second one is thoracal paravertebral block group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-25', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2022-07-25', 'lastUpdatePostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt)', 'timeFrame': 'Postoperative 24 hours period', 'description': 'Change from Baseline Pain Scores at Postoperative 24 hours.'}], 'secondaryOutcomes': [{'measure': 'The need for rescue analgesia', 'timeFrame': 'Postoperative 24 hours period', 'description': 'The amount of Tramodol using (mg)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiovascular surgery', 'Postoperative pain management', 'Erector Spinae Plane Block', 'Thoracal paravertebral block'], 'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '30114712', 'type': 'BACKGROUND', 'citation': 'El Shora HA, El Beleehy AA, Abdelwahab AA, Ali GA, Omran TE, Hassan EA, Arafat AA. Bilateral Paravertebral Block versus Thoracic Epidural Analgesia for Pain Control Post-Cardiac Surgery: A Randomized Controlled Trial. Thorac Cardiovasc Surg. 2020 Aug;68(5):410-416. doi: 10.1055/s-0038-1668496. Epub 2018 Aug 16.'}, {'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': '27501016', 'type': 'BACKGROUND', 'citation': 'Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.'}, {'pmid': '29169795', 'type': 'BACKGROUND', 'citation': "D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4."}]}, 'descriptionModule': {'briefSummary': 'Pain is a common and serious problem after cardiovascular surgery. It is associated with increased morbidity and mortality, and additional risk factors of cardiac surgery such as sternotomy and cardiopulmonary bypass contribute to this. Patient-controlled analgesia with intravenous opioids is standard in many centers for the management of pain after cardiac surgery. However, intravenous opioids have a higher risk of nausea and vomiting and may delay weaning from mechanical ventilation compared to regional techniques. Elderly patients have a higher risk of opioid-related complications, and regional techniques can help reduce postoperative ventilation time and accelerate postoperative recovery, which will reduce the risk of atelectasis, especially in the elderly population. Thoracic paravertebral block (TPVB) is difficult to apply due to its anatomical proximity to important structures such as the pleura and central neuraxial system, and may cause complications such as pneumothorax and vascular injury. Analgesia management is very important in these patients, since insufficient analgesia may cause pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption in the postoperative period.\n\nErector spina plane (ESP) block performed with ultrasound (US) is a new interfacial plane block defined by Forero et al. in 2016. If the ESP block is applied at the T5 level, it provides thoracic analgesia, if it is applied at the T7-9 level, it provides analgesia in the abdominal region.\n\nIn this study, it is aimed to compare the effectiveness of US-guided ESP block and TPVB for postoperative analgesia management after cardiovascular surgery. Our primary aim is to compare postoperative pain scores (NRS), and our secondary aim is to evaluate rescue analgesia using, opioid-related side effects (allergic reaction, nausea, vomiting) and complications that may occur due to block (pneumothorax, hematoma).', 'detailedDescription': 'Pain is a common and serious problem after cardiovascular surgery. It is associated with increased morbidity and mortality, and additional risk factors of cardiac surgery such as sternotomy and cardiopulmonary bypass contribute to this. Patient-controlled analgesia with intravenous opioids is standard in many centers for the management of pain after cardiac surgery. However, intravenous opioids have a higher risk of nausea and vomiting and may delay weaning from mechanical ventilation compared to regional techniques. Elderly patients have a higher risk of opioid-related complications, and regional techniques can help reduce postoperative ventilation time and accelerate postoperative recovery, which will reduce the risk of atelectasis, especially in the elderly population. Thoracic paravertebral block (TPVB) is difficult to apply due to its anatomical proximity to important structures such as the pleura and central neuraxial system, and may cause complications such as pneumothorax and vascular injury. Analgesia management is very important in these patients, since insufficient analgesia may cause pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption in the postoperative period.\n\nErector spina plane (ESP) block performed with ultrasound (US) is a new interfacial plane block defined by Forero et al. in 2016. If the ESP block is applied at the T5 level, it provides thoracic analgesia, if it is applied at the T7-9 level, it provides analgesia in the abdominal region. This block is applied by injecting a solution containing local anesthetic into the fascia under the erector spina muscle. Since the application site of the ESP block is far from the pleura and neuraxial tissues, it minimizes the risk of complications due to injury to these structures. Sonoanatomy is easy to visualize on US and the spread of local anesthetic can be seen easily. With the cephalo-caudal spread of the local anesthetic solution, analgesia occurs in several dermatomes. Cadaveric studies have shown that the injection spreads to the ventral and dorsal roots of the spinal nerves and creates sensory blockade in both the anterolateral thorax and the posterior. In the literature, it has been reported that it provides effective analgesia in randomized controlled studies investigating the effectiveness of ESP block for postoperative analgesia management after open heart surgery, breast surgery and ventral hernia repair.\n\nIn this study, it is aimed to compare the effectiveness of US-guided ESP block and TPVB for postoperative analgesia management after cardiovascular surgery. Our primary aim is to compare postoperative pain scores (NRS), and our secondary aim is to evaluate rescue analgesia using, opioid-related side effects (allergic reaction, nausea, vomiting) and complications that may occur due to block (pneumothorax, hematoma).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) classification I-III\n* Scheduled for cardiovascular surgery under general anesthesia\n\nExclusion Criteria:\n\n* Bleeding diathesis\n* anticoagulant treatment\n* local anesthetics and opioid allergy\n* Infection of the skin at the site of the needle puncture\n* Patients who do not accept the procedure'}, 'identificationModule': {'nctId': 'NCT05476393', 'briefTitle': 'ESPB vs TPVB for Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Comparison of Effectiveness of Erector Spinae Plane Block and Thoracal Paravertebral Block for Postoperative Analgesia After Cardiovascular Surgery: Randomized Study', 'orgStudyIdInfo': {'id': 'Medipol Hospital 28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Erector spinae block (Group ESPB)', 'description': 'ESP block will be applied in Group ESPB. The US probe will be placed longitudinally 2-3 cm lateral to the T5 transverse process. Three muscles from top to bottom; Trapezius at the top, rhomboid major in the middle, and the erector spina muscle at the bottom will be displayed over the hyperechoic transverse process. Using the in plane technique, the block needle will be advanced in the cranio-caudal direction and 5 ml of saline will be injected under the erector spina muscle and the block location will be confirmed. After the block location is confirmed, 40 ml of 0.25% bupivacaine will be administered (20 ml in each side).', 'interventionNames': ['Other: Postoperative management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracal paravertebral block group (Group TPVB)', 'description': 'After visualizing the T5 spinous process sagittally with the US probe, the probe will be placed 2-3 cm laterally. The ribs and transverse processes will be displayed as hyperechoic structures. Superiorly, the costotransverse ligament and anteriorly the pleura will be visualized. With the in-plane technique, the block needle will be advanced in the cranio-caudal direction until the costotransverse ligament is passed. 5 ml of saline will be injected and the block location will be confirmed. After confirming the location of the needle, negative aspiration is performed, and after observing the absence of CSF, blood and air, 40 ml of 0.25% bupivacaine will be administered, and it will be seen that the pleura is pushed down as the drug is administered (20 ml in each side).', 'interventionNames': ['Other: Postoperative management']}], 'interventions': [{'name': 'Postoperative management', 'type': 'OTHER', 'description': '1 g paracetamol will be administered 3 x 1. If the NRS score is ≥ 4, 1 mg kg-1 iv tramadol will be administrated.', 'armGroupLabels': ['Erector spinae block (Group ESPB)', 'Thoracal paravertebral block group (Group TPVB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34070', 'city': 'Istanbul', 'state': 'Bagcilar', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary researcher', 'investigatorFullName': 'Bahadir Ciftci', 'investigatorAffiliation': 'Medipol University'}}}}