Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-31 @ 2:30 AM
Study NCT ID:
NCT05083832
Status:
COMPLETED
Last Update Posted:
2024-03-06
First Post:
2021-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Two Different Plane Blocks on Post-thoracotomy Pain
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2021-10-06', 'studyFirstSubmitQcDate': '2021-10-06', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': '72 hours after surgery', 'description': 'Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th, 24th, 48th and 72nd hours after surgery.'}], 'secondaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': '24 hours after surgery', 'description': 'Morphine consumption for 24 hours will be recorded'}, {'measure': 'Side effects', 'timeFrame': '72 hours after surgery', 'description': 'Side effects, such as allergy to local anesthetics, hypotension, nausea/vomiting, itching, headache, and sweating will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain, Postoperative', 'Thoracotomy', 'Erector spinae plane block', 'Serratus anterior plane block'], 'conditions': ['Pain, Postoperative', 'Thoracotomy', 'Erector Spinae Plane Block', 'Serratus Anterior Plane Block']}, 'descriptionModule': {'briefSummary': 'Thoracotomy is recognized as one of the most painful surgical procedures. This increases the frequency of postoperative pulmonary complications. Erector Spinae Plane Block (ESPB) and Serratus Anterior Plane Block (SAPB) are more superficial, easier to perform, and less likely to have complications. In addition, ESPB and SAPB applications are increasing in patients who underwent thoracotomy and thoracoscopic surgery.\n\nIn this study, the investigators aimed to evaluate the effect of continuous ESPB and continuous SAPB via US-guidance on post-thoracotomy pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years old\n* ASA physical status I-II-III\n* BMI 18 to 30 kg/m2\n* Elective thoracotomy surgery\n\nExclusion Criteria:\n\n* Patient refusing the procedure\n* Emergency surgery\n* History of chronic opioid or analgesic used'}, 'identificationModule': {'nctId': 'NCT05083832', 'briefTitle': 'Effect of Two Different Plane Blocks on Post-thoracotomy Pain', 'organization': {'class': 'OTHER', 'fullName': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital'}, 'officialTitle': 'Effects of Ultrasound-guided Continuous Erector Spina Plane Block and Continuous Serratus Anterior Plane Block on Post-thoracotomy Pain', 'orgStudyIdInfo': {'id': 'E.Kurul-E1-21-1863'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous erector spinae plane block', 'description': 'Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area. A catheter will be placed in this area. Then, 5 ml/hour 0.125% bupivacaine will be infused via erector spinae plane block catheter.', 'interventionNames': ['Procedure: Continuous Erector Spina Plane Block vs Continuous Serratus Anterior Plane Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuous serratus anterior plane block', 'description': 'Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the serratus anterior muscles until the fourth rib area. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area. A catheter will be placed in this area. Then, 5 ml/hour 0.125% bupivacaine will be infused via serratus anterior plane block catheter.', 'interventionNames': ['Procedure: Continuous Erector Spina Plane Block vs Continuous Serratus Anterior Plane Block']}], 'interventions': [{'name': 'Continuous Erector Spina Plane Block vs Continuous Serratus Anterior Plane Block', 'type': 'PROCEDURE', 'description': 'Two different catheter techniques with same doses local anesthetic infusion', 'armGroupLabels': ['Continuous erector spinae plane block', 'Continuous serratus anterior plane block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Keçiören', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital', 'geoPoint': {'lat': 40.00132, 'lon': 32.87238}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal İnvestigator', 'investigatorFullName': 'Musa Zengin', 'investigatorAffiliation': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital'}}}}