Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-01-04 @ 7:23 PM
Study NCT ID:
NCT03210220
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2017-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Preoperative Pectoral Nerve Block for Intraoperative Opioid Sparing Effect and Postoperative Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jjchoi2@gilhospital.com', 'phone': '82-32-460-3636', 'title': 'Dr Junju Choi', 'organization': 'Department of Anesthesiology and Pain Medicine, Gil Medical Center, Gachon University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3days', 'eventGroups': [{'id': 'EG000', 'title': 'Pecs Group', 'description': 'Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'There is no block.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraoperative Remifentanil Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pecs Group', 'description': 'Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'There is no block.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.75', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '10.12', 'spread': '3.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'whole intraoperative period', 'description': 'Intraoperative remifentanil consumption during surgery(whole intraoperative period)', 'unitOfMeasure': 'μg/kg/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pecs Group', 'description': 'Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'There is no block.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pecs Group', 'description': 'Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'There is no block.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'spread': '7.71', 'groupId': 'BG000'}, {'value': '52.7', 'spread': '9.22', 'groupId': 'BG001'}, {'value': '52.07', 'spread': '8.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'weight', 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'spread': '10', 'groupId': 'BG000'}, {'value': '63.5', 'spread': '8', 'groupId': 'BG001'}, {'value': '61.5', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-16', 'size': 119542, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-28T22:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'One anesthesiologist (JJC) performed all blocks in the Pecs group enrolled patients. After the intervention, the participants and the investigator responsible for the study outcome assessment were blinded.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients either received the Pecs II block (Pecs group) or did not receive it (control group).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-28', 'studyFirstSubmitDate': '2017-07-04', 'resultsFirstSubmitDate': '2019-09-16', 'studyFirstSubmitQcDate': '2017-07-05', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-28', 'studyFirstPostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative Remifentanil Consumption', 'timeFrame': 'whole intraoperative period', 'description': 'Intraoperative remifentanil consumption during surgery(whole intraoperative period)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether pectoral nerves blocks（PECS） would reduces the opioid consumption during the surgery and postoperative pain after breast cancer surgery.', 'detailedDescription': 'Forty adult female participants scheduled for elective breast cancer surgery under general anesthesia are randomly allocated to receive either general anesthesia plus Pecs block(Pecs group, n=20) or general anesthesia alone (control group, n=20).\n\nAfter arrived in the operating room，all patients undergo operation under total intravenous anesthesia (TIVA) with or without pectoral nerves blocks(PECS) . After anesthesia induction，the participants in the Pecs group receive an ultrasound-guided Pecs block before the start of the operation.\n\nPecs block technology：After cleaning the infraclavicular and axillary regions , the linear probe is placed below the lateral third of the clavicle. After recognition of the appropriate anatomical structures, then the block is performed . The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .\n\nDuring operation the remifentanil administration in each group is guided using the surgical pleth index( SPI). the SPI target range was 20 to 50 Anesthetic depth is maintained and continuously adjusted with propofol to achieve Bispectral Index (BIS) between 40 and 60.\n\nprimary outcome intraoperative remifentanil consumption secondaty outcome postoperative pain score and rescue analgesic requirement'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAmerican Society of Anesthesiologists( ASA) I or II Scheduled for breast cancer surgery\n\nExclusion Criteria:\n\nSensitivity to local anesthetic, Bleeding disorders , Receiving anticoagulant, Body mass index (BMI) \\> 35/kg/m2 , Spine or chest wall deformity , Pregnancy'}, 'identificationModule': {'nctId': 'NCT03210220', 'briefTitle': 'Efficacy of Preoperative Pectoral Nerve Block for Intraoperative Opioid Sparing Effect and Postoperative Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'Efficacy of Preoperative Ultrasound Guided Pectoral Nerve Block for Intraoperative Opioid Sparing Effect and Postoperative Analgesia in Patients Undergoing Surgery for Breast Cancer.', 'orgStudyIdInfo': {'id': 'PENBreast'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pecs group', 'description': 'Ultrasound guided pectoral nerve block is performed right after induction, before surgery. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.5% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib between the pectoralis minor muscle and the serratus anterior muscle .', 'interventionNames': ['Procedure: Pecs II block']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'There is no block.'}], 'interventions': [{'name': 'Pecs II block', 'type': 'PROCEDURE', 'description': 'After identifying the axillary vein and artery, the ultrasound probe was positioned inferio-laterally, between the 3rd and 4th ribs, and then the pectoralis major and minor, and serratus anterior muscles were confirmed. The needle was advanced in a medio-lateral direction in-plane view of the ultrasound. For the Pecs II block, a total 30 mL of 0.5% ropivacaine was injected. First, the needle tip was advanced into the fascia between the pectoralis major and minor muscles and 10 mL of 0.5% ropivacaine was injected. Thereafter, the needle tip was advanced into the tissue plane between the pectoralis minor and serratus anterior muscles, and 20 mL of 0.5% ropivacaine was injected in a similar manner.', 'armGroupLabels': ['pecs group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22241', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Kyung Cheon Lee', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'overallOfficials': [{'name': 'Kyung Cheon Lee', 'role': 'STUDY_CHAIR', 'affiliation': 'Gachon University Gil Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistance professor', 'investigatorFullName': 'Jung Ju Choi', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}