Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-05 @ 3:47 PM
Study NCT ID:
NCT06098859
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2023-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain in Open Heart Surgeries
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants did not know which method was applied to them. Those who evaluated the research results did not know the groups'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The effects of thoracic epidural analgesia and erector spinae plane block on postoperative pain were compared with the control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2023-10-23', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'Postoperative 48 hours', 'description': 'Patients were asked about their pain levels. Rating done with VRS (Verbal Rating Scale).\n\nPain levels were evaluated between 0 and 10 points. 0: No pain (the best)….. 10: Unbearable pain (the worst)'}, {'measure': 'Respiratory functions', 'timeFrame': 'Postoperative 48 hours', 'description': 'Oxygen requirement:If more than 4 l/min oxygen support via face mask is required to maintain peripheral oxygen saturation (SpO2) above 90%, it is defined as oxygen requirement.\n\nTachypnea:more than 20/min\n\nFever: more than 37 C celcius\n\nNon invasive mechanical ventilation requirement:To patients whose breathing is impaired after extubation (who have tachypnea and have SpO2 less than 90% despite receiving oxygen support of more than 4 l/min oxygen support via face mask)'}], 'secondaryOutcomes': [{'measure': 'Analgesic requirement. When the VRS was more than 4 points', 'timeFrame': 'Postoperative 48 hours', 'description': 'diclofenac (75 mg), tramadol (50mg)'}, {'measure': 'Intensive care and hospital stay', 'timeFrame': 'postoperative 30 days', 'description': 'time for Intensive care and hospital (hours and days, respectively)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracic epidural analgesia', 'erector spinae plane block', 'heart surgery'], 'conditions': ['Pain, Postoperative', 'Respiratory Complication']}, 'descriptionModule': {'briefSummary': 'Postoperative pain negatively effects respiratory functions in open heart surgeries. The aim of the study is to compare the effects of thoracic epidural analgesia (TEA) and erector spinae plane block (ESPB) on postoperative pain and respiratory functions in patients undergoing open heart surgery with sternotomy', 'detailedDescription': 'Thoracic epidural catheter was inserted to patients in Group T at the T4-T5 vertebra level before induction of general anesthesia. And then local anesthetic infusion was started until postoperative 48. hours.\n\nBilateral erector spinae plan block was applied with total 40 ml of local anesthetic solution to patients in Group E at the T4-T5 vertebra level before induction of general anesthesia.\n\nThe control group was infused with 1 mcg/kg/min fentanyl during the surgery. In the postoperative period, 1 g paracetamol was infused 4 times a day.\n\nAll patients underwent general anesthesia with the same method and medications.\n\nTramadol/diclofenac was administered to patients with a pain score (NRS) above 4. NRS and tidal volumes (TV) of the patients were measured at 0, 2, 6, 12, 24, 36 and 48. hours after extubation. Postoperative mechanical ventilation durations, intensive care unit and hospital stays, additional analgesic needs and respiratory complications of the patients were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has ASA II-IV score\n* Having open heart surgery\n\nExclusion Criteria:\n\n* Having a psychiatric illness\n* Using analgesic medication due to chronic pain\n* Uncooperative'}, 'identificationModule': {'nctId': 'NCT06098859', 'briefTitle': 'Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain in Open Heart Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': "Comparison of the Effects of Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain and Respiratory Fonctions in Open Heart Surgeries''", 'orgStudyIdInfo': {'id': '2023/184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thoracic epidural analgesia', 'description': 'Thoracic epidural analgesia have been started preoperatively and coninuoed until postoperative 48 hours', 'interventionNames': ['Procedure: Thoracic epidural analgesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erector spinae plane block', 'description': 'Erector spinae plane blockwas applied preoperatively', 'interventionNames': ['Procedure: Erector spinae plane block']}, {'type': 'NO_INTERVENTION', 'label': 'Intravenous opioid analgesia', 'description': 'Intravenous opioid analgesia was administered during the surgery'}], 'interventions': [{'name': 'Thoracic epidural analgesia', 'type': 'PROCEDURE', 'description': 'Thoracic epidural analgesia was started preoperatively and rest posoperative 48 hours', 'armGroupLabels': ['Thoracic epidural analgesia']}, {'name': 'Erector spinae plane block', 'type': 'PROCEDURE', 'description': 'Erector spinae plane block was applied preoperatively using local anesthetic', 'armGroupLabels': ['Erector spinae plane block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61080', 'city': 'Ortahisar', 'state': 'Trabzon', 'country': 'Turkey (Türkiye)', 'facility': 'Engin Ertürk'}], 'overallOfficials': [{'name': 'Engin Ertürk, Prof. Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karadeniz Technical University, Medical Faculty, Anesthesiology and Intensive Care'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'starting12 months after publication', 'ipdSharing': 'YES', 'description': 'all collected IPD', 'accessCriteria': 'analyst and investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karadeniz Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr', 'investigatorFullName': 'Engin Ertürk', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}