Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-29 @ 11:27 AM
Study NCT ID:
NCT04702061
Status:
COMPLETED
Last Update Posted:
2021-04-20
First Post:
2020-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Erector Spina Plane Block and Thoracic Epidural Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-19', 'studyFirstSubmitDate': '2020-12-24', 'studyFirstSubmitQcDate': '2021-01-07', 'lastUpdatePostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sympathetic block level evaluation with skin conductivity', 'timeFrame': '45 minutes after block administration', 'description': 'Skin conductivity will be measured by galvanic skin response (GSR)'}, {'measure': 'Sympathetic block level evaluation with skin temperature', 'timeFrame': '45 minutes after block administration', 'description': 'Skin temperature of bilateral thorax will be measured'}, {'measure': 'Sympathetic block level evaluation with hot cold test', 'timeFrame': '45 minutes after block administration', 'description': 'Hot cold test of bilateral thorax will be measured'}, {'measure': 'Sympathetic block level evaluation by hemodynamic data', 'timeFrame': '45 minutes after block administration', 'description': 'Peri-operative heart rate and mean arterial pressure will be recorded'}, {'measure': 'Sensorial block level evaluation', 'timeFrame': '45 minutes after block administration', 'description': 'By pin-prick test'}], 'secondaryOutcomes': [{'measure': 'intraoperative hemodynamic data', 'timeFrame': 'During the operation', 'description': 'Heart rate and mean arterial pressure'}, {'measure': 'Postoperative pain scores', 'timeFrame': '24 hours after operation', 'description': 'Pain score will be measured with visual analog scale (0-no pain; 10-worst pain) during movement and rest.'}, {'measure': 'Rescue analgesics consumption', 'timeFrame': 'During the operation and 24 hours after operation', 'description': 'Amount of remifentanil (microgram)'}, {'measure': 'Rescue analgesics consumption', 'timeFrame': '24 hours after operation', 'description': 'Amount of tramadol (milligram)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Neoplasms', 'Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The aim of this randomised controlled and double-blind study, is to compare the effects of erector spinae plane (ESP) and thoracic epidural (TEA) blocks on peri-operative hemodynamics and analgesia in patients undergoing unilateral mastectomies due to malignancy.', 'detailedDescription': 'Patients will be randomised into two groups as Group E (those who received general anesthesia after the erector spina plan block) and Group T (those who received general anesthesia after thoracic epidural block).\n\nAfter the block skin conductivity (galvanic skin response - GSR), body temperature changes, sympathetic and sensory block levels, peri-operative hemodynamic data, postoperative pain scores and analgesic consumption will be recorded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA(American Society of Anesthesiologist) physical classification I-III\n* Patients undergoing unilateral mastectomies due to malignancy\n\nExclusion Criteria:\n\n* Active infection at the intervention site\n* History of coagulopathy or anticoagulant use (less time has passed before peripheral and central blocks)\n* Major cardiac, pulmonary, renal and neurological diseases\n* Autonomic neuropathy or use of drugs that affect autonomic function\n* Patients with type 1 diabetes or insulin dependent type 2 diabetes over 10 years\n* Allergic to local anesthetics;\n* Patients who are uncooperative or have psychiatric problems\n* Morbidly obese (body mass index \\> 35 kg/m2)'}, 'identificationModule': {'nctId': 'NCT04702061', 'briefTitle': 'Comparison of Erector Spina Plane Block and Thoracic Epidural Block', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'Comparison of Erector Spina Plane Block and Thoracic Epidural Block in Breast Surgery', 'orgStudyIdInfo': {'id': 'Esogu Anesthesia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group E', 'description': 'Patients who receive general anesthesia after erector spina plane block', 'interventionNames': ['Other: Erector spina plane block before general anaesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group T', 'description': 'Patients who receive general anesthesia after thoracic epidural block', 'interventionNames': ['Other: Thoracic epidural block before general anaesthesia']}], 'interventions': [{'name': 'Erector spina plane block before general anaesthesia', 'type': 'OTHER', 'description': 'After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be directed between the erector spina muscle and the transverse process of the T4 vertebra using the in-plane technique. The location of the needle will be confirmed by hydrodissection with saline after touching the transverse process. After the plan open, 5 ml of 2% lidocaine, 10 ml of 0.5% bupivacaine and 10 ml of saline, including hydrodissection, will be given in a total amount of 25 ml. Then a 20-G epidural catheter will be inserted 3-4 cm and fixed.', 'armGroupLabels': ['Group E']}, {'name': 'Thoracic epidural block before general anaesthesia', 'type': 'OTHER', 'description': 'After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be entered through the T4-5 interspinous space (median or paramedian approach). After reaching the thoracic epidural area by loss of resistance method, the epidural catheter will be advanced and fixed to remain 3-4 cm in the epidural area. Following the test dose (2 ml of 2% lidocaine), 3 ml of 2% lidocaine, 5 ml of 0.5% bupivacaine and 5 ml of saline will be administered intermittently in a total volume of 15 ml.', 'armGroupLabels': ['Group T']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Eskişehir', 'country': 'Turkey (Türkiye)', 'facility': 'Eskisehir Osmangazi University', 'geoPoint': {'lat': 39.77667, 'lon': 30.52056}}], 'overallOfficials': [{'name': 'Gulay ERDOGAN KAYHAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor Doctor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD', 'investigatorFullName': 'Gulay ERDOGAN KAYHAN', 'investigatorAffiliation': 'Inonu University'}}}}