Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:37 AM
Study NCT ID:
NCT07432256
Status:
COMPLETED
Last Update Posted:
2026-02-25
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parasternal Block Added to Serratus Anterior Plane Block in Breast Reduction Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], '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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D049231', 'term': 'Saposins'}], 'ancestors': [{'id': 'D049128', 'term': 'Sphingolipid Activator Proteins'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total postoperative opioid consumption in the first 24 hours', 'timeFrame': 'First 24 hours after surgery', 'description': 'Total opioid consumption during the first 24 postoperative hours will be recorded and compared between the study groups.'}], 'secondaryOutcomes': [{'measure': 'Quality of recovery by using QoR-15 questionnaire', 'timeFrame': 'postoperative 24th hour'}, {'measure': 'Pain Scores', 'timeFrame': 'postoperative 0, 1, 2, 6, 12, 24 th hour', 'description': 'using NRS Scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['serratus anterior plane block', 'parasternal intercostal plane block', 'breast reduction surgery', 'pain management', 'postoperative pain', 'QoR-15'], 'conditions': ['Breast Reduction', 'Postoperative Pain', 'Opioid Consumption']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of adding a Superficial Parasternal Intercostal Plane Block (PIPB) to the Serratus Anterior Plane Block (SAPB) on postoperative pain control in patients undergoing breast reduction surgery under general anesthesia. Effective postoperative analgesia is essential to reduce opioid consumption and improve recovery.\n\nAll patients will receive standard general anesthesia. Patients will be allocated into three groups: a control group receiving no regional block, a group receiving SAPB alone, and a group receiving SAPB combined with PIPB. The primary outcome of the study is total opioid consumption within the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, Quality of Recovery-15 (QoR-15) scores, and intraoperative remifentanil consumption.\n\nThe study aims to determine whether SAPB reduces postoperative opioid requirements compared to no block, and whether adding PIPB provides additional analgesic benefit by blocking the anterior cutaneous branches of the intercostal nerves. The findings may contribute to improving multimodal analgesia strategies in breast surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 18-65 years\n* Scheduled for elective breast reduction surgery under general anesthesia\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Ability to understand the study and provide written informed consent\n\nExclusion Criteria:\n\n* Patient refusal\n\n * Known allergy to local anesthetics\n * Coagulopathy or ongoing anticoagulant therapy\n * Infection at the block site\n * Chronic opioid use or opioid dependence\n * Severe hepatic or renal insufficiency\n * Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT07432256', 'briefTitle': 'Parasternal Block Added to Serratus Anterior Plane Block in Breast Reduction Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Zonguldak Bulent Ecevit University'}, 'officialTitle': 'The Effect of Adding a Parasternal Intercostal Plane Block to a Serratus Anterior Plane Block on Postoperative Opioid Consumption in Breast Reduction Surgery', 'orgStudyIdInfo': {'id': '2024/08-6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'patients receive standard general anesthesia'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Serratus Anterior Plane Block', 'description': 'patients receive an ultrasound guided anterior serratus plane block in addition to general anesthesia before surgery', 'interventionNames': ['Procedure: Serratus Anterior Plane Block (SAPB)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Serratus Anterior Plane Block + Parasternal Intercostal Plane Block', 'description': 'patients receive an ultrasound guided anterior serratus plane block combined with a parasternal plane block in addition to general anesthesia before surgery', 'interventionNames': ['Procedure: Serratus Anterior Plane Block (SAPB) and parasternal intercostal plane block']}], 'interventions': [{'name': 'Serratus Anterior Plane Block (SAPB)', 'type': 'PROCEDURE', 'description': 'injection local anesthetic between 5th rib and serratus anterior muscle', 'armGroupLabels': ['Serratus Anterior Plane Block']}, {'name': 'Serratus Anterior Plane Block (SAPB) and parasternal intercostal plane block', 'type': 'PROCEDURE', 'description': 'both injection local anesthetic between 5th rib and serratus anterior muscle at midaxillary line and between 4th costal cartilage and pectoralis major muscle at next to the sternum', 'armGroupLabels': ['Serratus Anterior Plane Block + Parasternal Intercostal Plane Block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zonguldak', 'state': 'Maltepe', 'country': 'Turkey (Türkiye)', 'facility': 'Zonguldak Bulent Ecevit University Hospital', 'geoPoint': {'lat': 41.45139, 'lon': 31.79305}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zonguldak Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'emine bayraktar', 'investigatorAffiliation': 'Zonguldak Bulent Ecevit University'}}}}