Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-01-07 @ 7:41 AM
Study NCT ID:
NCT03309267
Status:
COMPLETED
Last Update Posted:
2017-11-07
First Post:
2017-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serratus Anterior Plane Block Versus Intercostal Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-03', 'studyFirstSubmitDate': '2017-10-06', 'studyFirstSubmitQcDate': '2017-10-12', 'lastUpdatePostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complications', 'timeFrame': 'Postoperative 1 week', 'description': 'Postoperative Complications'}], 'primaryOutcomes': [{'measure': 'Postoperative analgesic consumption', 'timeFrame': 'up to 24 hour', 'description': 'Postoperative analgesic consumption'}], 'secondaryOutcomes': [{'measure': 'Visuel analog scala (VAS)', 'timeFrame': 'up to 24 hour', 'description': '1.,2.,4.,6.,12.,24. hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain, thoracotomy'], 'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '28447227', 'type': 'BACKGROUND', 'citation': 'Okmen K, Okmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26.'}]}, 'descriptionModule': {'briefSummary': 'Pain after thoracotomy is the most severe pain experienced by the patient. Good pain control after the operation provides comfortable respiration and reduces the development of chronic pain and complications.\n\nwe aimed to compare SAPB with IBregarding postoperative visual analog scale (VAS) scores and analgesic consumption in patients undergoing thoracotomy operation.', 'detailedDescription': 'Patients who underwent thoracotomy operation in our hospital between May 2016 and June 2017 were examined. A retrospective evaluation was made of the data that was retrieved from the records of a total of 49 patients aged 18-75 years, ASA I-III, who were applied with Intercostal (IB) or Serratus anterior plane(SAPB) for a thoracotomy operation. The patient information was retrieved from the patient records and anesthesia block forms. The data were examined in respect of age, sex, height, weight, ASA, operation type, operating time, the amount of postoperative analgesic consumption, VAS at 1.,2.,4.,6.,12.,24. hours and complications (atelectasis, nausea, vomiting, hypotension and bradycardia).\n\nStatistical analysis was performed using the SPSS program for Mac, version 17.0 (SPSS,Chicago,IL). Descriptive statistics are presented as mean and SD, and as the number of cases (n) and the corresponding percentage (%) for nominal variables. T tests were performed for normally continuous variables. The Mann-Whitney U test was used for non-parametric variables. A value of p \\< 0.05 was considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Thoracotomy Operation', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Thoracotomy operation\n2. a.Serratus anaterior plane block b.Intercostal block\n\nExclusion Criteria:\n\n1. missing data\n2. written consent\n3. rethoracotomy'}, 'identificationModule': {'nctId': 'NCT03309267', 'briefTitle': 'Serratus Anterior Plane Block Versus Intercostal Block', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'Serratus Anterior Plane Block Versus Intercostal Block For Postoperative Analgesia Following Thoracotomy', 'orgStudyIdInfo': {'id': '2017/14-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intercostal block', 'description': 'Anesthesia induction was performed to all patients .At the end of the operation some patients were performed with intercostal block by the chest surgeon. For 24 hours postoperatively, tramadol was administered with patient-controlled analgesia (PCA) All patients were extubated after the operation and transferred to ICU.', 'interventionNames': ['Procedure: Intercostal block']}, {'label': 'Serratus anterior plane block', 'description': 'Anesthesia induction was performed to all patients. At the end of the operation some patients were performed SAPB under Ultrasound guidance by the same anesthetist.For 24 hours postoperatively, tramadol was administered with patient-controlled analgesia (PCA) All patients were extubated after the operation and transferred to ICU.', 'interventionNames': ['Procedure: Serratus anterior plane block']}], 'interventions': [{'name': 'Intercostal block', 'type': 'PROCEDURE', 'description': 'Intercostal block +patient controlled analgesia', 'armGroupLabels': ['Intercostal block']}, {'name': 'Serratus anterior plane block', 'type': 'PROCEDURE', 'description': 'Serratus anterior plane block+patient controlled analgesia', 'armGroupLabels': ['Serratus anterior plane block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46100', 'city': 'Kahramanmaraş', 'country': 'Turkey (Türkiye)', 'facility': 'KahramanmarasSIU', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}], 'overallOfficials': [{'name': 'Gözen Öksüz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kahramanmaras Sutcu Imam University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gözen Öksüz', 'investigatorAffiliation': 'Kahramanmaras Sutcu Imam University'}}}}