Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT03217292
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2017-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serratus Anterior Plane Block for Pain Treatment After Video-Assisted Thoracoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}, {'id': 'D010323', 'term': 'Passive Cutaneous Anaphylaxis'}, {'id': 'D014147', 'term': 'Tramadol'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D000937', 'term': 'Antigen-Antibody Reactions'}, {'id': 'D055633', 'term': 'Immune System Phenomena'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, controlled, single-blind'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-13', 'studyFirstSubmitDate': '2017-07-02', 'studyFirstSubmitQcDate': '2017-07-11', 'lastUpdatePostDateStruct': {'date': '2017-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'side effect profile', 'timeFrame': '24 hours', 'description': 'side effect profile'}, {'measure': 'additional analgesic use', 'timeFrame': '24 hours', 'description': 'additional analgesic use'}], 'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'Postoperative 24 hours', 'description': 'Visual Analogue Scale was used for pain'}], 'secondaryOutcomes': [{'measure': 'tramadol consumption', 'timeFrame': 'Postoperative 24 hour', 'description': 'tramadol consumption'}, {'measure': 'Ramsay sedation scale (RSS)', 'timeFrame': '24 hours', 'description': 'Ramsay sedation scale (RSS)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nerve Block']}, 'descriptionModule': {'briefSummary': 'Analgesia following video-assisted thoracoscopic surgery (VATS) is important for the prevention of postoperative pulmonary complications.Various regional methods of anesthesia are currently being used to achieve this goal. The aim of the study was to assess the effectiveness of SAPB on postoperative VATS analgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent video-assisted thoracoscopic surgery (VATS).\n\nExclusion Criteria:\n\n* Previous history of opioid use preoperatively,\n* Allergy to local anesthetics,\n* The presence of any systemic infection,\n* Uncontrolled arterial hypertension,\n* Uncontrolled diabetes mellitus.'}, 'identificationModule': {'nctId': 'NCT03217292', 'briefTitle': 'Serratus Anterior Plane Block for Pain Treatment After Video-Assisted Thoracoscopic Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'Evaluation of the Effect of Serratus Anterior Plane Block for Pain Treatment After Video-Assisted Thoracoscopic Surgery', 'orgStudyIdInfo': {'id': '2011-KAEK-25 2016/13-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group S', 'description': 'IV patient-controlled analgesia (PCA) tramadol+Serratus Anterior Plane Block(SAPB) Tramadol infusion (PCA): 400 mg tramadol, IV 4 mg/mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.\n\n20 mL of bupivacaine at a concentration of 0.25% to between serratus anterior and intercostal muscle using the in-line technique for SAPB.', 'interventionNames': ['Procedure: Serratus Anterior Plane Block', 'Drug: IV patient-controlled analgesia (PCA) tramadol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group T', 'description': 'IV patient-controlled analgesia (PCA) tramadol Tramadol infusion (PCA): 400 mg tramadol, IV 4 mg/mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.', 'interventionNames': ['Drug: IV patient-controlled analgesia (PCA) tramadol']}], 'interventions': [{'name': 'Serratus Anterior Plane Block', 'type': 'PROCEDURE', 'armGroupLabels': ['Group S']}, {'name': 'IV patient-controlled analgesia (PCA) tramadol', 'type': 'DRUG', 'armGroupLabels': ['Group S', 'Group T']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Burcu Metin Ökmen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Korgün Ökmen', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}