Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 12:19 AM
Study NCT ID:
NCT04855994
Status:
COMPLETED
Last Update Posted:
2021-07-09
First Post:
2021-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Thoracic Paravertebral Block and Pectoral Nerve Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-04', 'studyFirstSubmitDate': '2021-04-09', 'studyFirstSubmitQcDate': '2021-04-20', 'lastUpdatePostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative 24-hours total morphine consumption of patients', 'timeFrame': '24 hours postoperatively', 'description': 'This will be measured only one time by pca device at the 24th hour after surgery.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale values of patients', 'timeFrame': '24 hours postoperatively', 'description': 'Visual Analog Scale (VAS, 0-10; 0= no pain and 10= very severe unbearable pain) at 0-1-2-4-8-12 and 24th hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thoracic paravertebral block,', 'pectoralis block,', 'Video-assisted thoracoscopic surgery,', 'Postoperative analgesia'], 'conditions': ['Thoracic Paravertebral Block', 'Video-assisted Thoracoscopic Surgery', 'Postoperative Analgesia']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficacy and safety of ultrasound-guidedPECS II block with TPVB for postoperative analgesia after VATS.', 'detailedDescription': '52 patients (ASA I-III) between 18 and 65 years of age, who were to undergo VATS, were randomized and divided into two groups. (26 patients in each of the PECS and TPVB groups) Thoracic paravertebral block was administered from two consecutive levels for TPVB group and a modified pectoral nerve block was performed in the PECS group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative 24-hour total morphine consumption and duration of analgesia were the primary outcome measure. Perioperative remifentanil use, visual analog scale values during at rest and coughing, time of the first analgesic request, and additional analgesic consumption were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages of 18-65\n* Patients who will undergo VATS\n* ASA I-II-III patients\n\nExclusion Criteria:\n\n* Patients with ASA IV\n* Clinically diagnosis of spinal or chest wall deformity or pathology\n* Clinically known local anesthetic allergy\n* Morbid obesity (body mass index\\>40 kg m2)\n* Clinically diagnosis of opioid, alcohol and substance dependence\n* Clinically diagnosis of psychiatric disease\n* Coagulopathy'}, 'identificationModule': {'nctId': 'NCT04855994', 'briefTitle': 'Comparison of Thoracic Paravertebral Block and Pectoral Nerve Block', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': 'Comparison of the Results of Ultrasound-Guided Thoracic Paravertebral Block and Modified Pectoral Nerve Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Surgery; A Prospective, Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2017-140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'paravertebral group', 'description': 'The investigators performed Paravertebral block to that patient group for postoperative analgesia', 'interventionNames': ['Procedure: paravertebral block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'pectoral group', 'description': 'The investigators performed pectoral block to that patient group for postoperative analgesia', 'interventionNames': ['Procedure: pectoral block']}], 'interventions': [{'name': 'paravertebral block', 'type': 'PROCEDURE', 'description': 'The investigators performed Paravertebral block to that patient group for postoperative analgesia', 'armGroupLabels': ['paravertebral group']}, {'name': 'pectoral block', 'type': 'PROCEDURE', 'description': 'The investigators performed pectoral block to that patient group for postoperative analgesia', 'armGroupLabels': ['pectoral group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34147', 'city': 'Istanbul', 'state': 'Bakirkoy', 'country': 'Turkey (Türkiye)', 'facility': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Gokhan Sertcakacilar, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD', 'investigatorFullName': 'Gokhan Sertcakacilar, MD', 'investigatorAffiliation': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}}}}