Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT06129305
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2023-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D001416', 'term': 'Back Pain'}], '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2023-08-14', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'distance of the erector spinae muscle from the skin in millimeters', 'timeFrame': 'two years', 'description': 'Our primary goal is to determine which thoracic level the erector spinae muscle is closer to the skin and whether the USG screen image is better.'}], 'secondaryOutcomes': [{'measure': 'clarity of the erector spinae muscle in different positions', 'timeFrame': 'two years', 'description': 'Our secondary goal is to find out in which position the erector spinae muscle is closer to the skin and the USG screen image is better.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erector spinae plane block', 'interfascial plan block.'], 'conditions': ['Pain, Postoperative', 'Pain, Back']}, 'descriptionModule': {'briefSummary': 'In our study, we aimed to calculate the ideal measurement of the distance of the erector spina muscle to the skin and to find the best ultrasonography image at different thoracic levels (T1-T2, T5-T6, T5-T6, T11-T12) and in other positions (lateral-sitting-pron) to improve the quality of the block in patients who will undergo erector spina plan block.\n\nOur primary goal is to determine which thoracic level the erector spinae muscle is closer to the skin and whether the USG screen image is better. Our secondary goal is to find out in which position the erector spinae muscle is closer to the skin and the USG screen image is better.', 'detailedDescription': '1- Abstract Introduction Erector spina plana block can be performed in different positions (sitting-lateral-pron) and at different thoracic levels. In our study, we aimed to calculate the ideal measurement of the distance of the erector spina muscle to the skin and to find the best ultrasonography image at different thoracic levels (T1-T2, T5-T6, T5-T6, T11-T12) and in other positions (lateral-sitting-pron) to improve the quality of the block in patients who will undergo erector spina plan block. Material and Methods A total of 80 patients (40 females and 40 males, ASA I-II) aged 18-65 years were included in the study. The erector spinae muscle was determined at T1-T2, T5-T6, and T11-T12 levels and in lateral, sitting, and prone positions, respectively, with a high frequency 10-15 millihertz linear probe of ultrasound, The distance from the skin to the midline of the ultrasound screen was measured, and the best ultrasound screen image was recorded. Erector spina plan block, distance measurement, different positions, interfascial plan block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '18-65 years with ASA (American Society of Anaesthesiologists) I-II patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients aged 18-65 years ASA (American Society of Anaesthesiologists) I-II who were to undergo cholecystectomy who were to undergo mastectomy who were to undergo inguinal hernia who were to undergo thoracic surgery\n\nExclusion Criteria:\n\nPatients in whom peripheral nerve block was contraindicated uncooperative patients disabled patients emergency cases patients with scoliosis pregnant and breastfeeding women patients with trauma incision scars in the measured area ASA III-IV-V group patients'}, 'identificationModule': {'nctId': 'NCT06129305', 'briefTitle': 'Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations', 'organization': {'class': 'OTHER', 'fullName': 'Konya City Hospital'}, 'officialTitle': 'Comparison of the Distance of the Erector Spina Muscle From the Skin at Different Thoracal Levels and Different posıtıons Under Ultrasonography', 'orgStudyIdInfo': {'id': 'konya city hospital'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Comparison of the distance of the Erector Spina muscle from the skin at different thoracal levels and different posıtıons under ultrasonography', 'type': 'OTHER', 'description': 'Comparison of the distance of the Erector Spina muscle from the skin at different thoracal levels and different posıtıons under ultrasonography'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Konya City Hospital', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}], 'overallOfficials': [{'name': 'MUHAMMED H SATICI, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konya City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not have such an opinion.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya City Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist, Department of Anesthesiology, Konya City Hospital, M.D', 'investigatorFullName': 'Muhammed Halit Satici', 'investigatorAffiliation': 'Konya City Hospital'}}}}