Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT07246720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IPP-PSP Block vs. SPSIPB in Breast Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'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': '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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative opioid consumption', 'timeFrame': 'in the first 24 hours after completion of the surgical procedure', 'description': 'Cumulative opioid consumption in the first 24 postoperative hours after the completion of the surgical procedure'}], 'secondaryOutcomes': [{'measure': 'Postsurgical Quality of Recovery measured by the Quality of Recovery questionnaire', 'timeFrame': 'first day after surgery', 'description': 'Postsurgical recovery by Quality of Recovery questionnaire (QoR-15) on first (D1) day after surgery.\n\nThe minimum score on the Quality of Recovery questionnaire is 0 and the maximum score 150. Higher scores mean better quality of recovery.'}, {'measure': 'Number of episodes of postoperative pain', 'timeFrame': 'In the first 24 hours after completion of the surgical procedure', 'description': 'Number of episodes of postoperative pain (NRS score ≥ 4) at rest and at deep inspiration in the first 24 postoperative hours after the completion of the surgical procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interpectoral-Pectoserratus Plane Block', 'Serratus Posterior Superior Intercostal Plane Block', 'Breast Cancer Surgery', 'Opioid Consumption', 'Pain Management'], 'conditions': ['Postoperative Acute Pain', 'Breast Cancer', 'Regional Anesthesia']}, 'descriptionModule': {'briefSummary': 'This prospective, randomized clinical study aims to compare the analgesic efficacy of the interpectoral-pectoserratus plane block and the serratus posterior superior intercostal plane block for postoperative pain management in patients undergoing breast cancer surgery. Both techniques are ultrasound-guided regional anesthesia methods targeting different interfascial planes of the thoracic wall. The study will evaluate postoperative pain scores, opioid consumption, Quality of recovery and potential complications. The findings are expected to contribute to optimizing regional anesthesia strategies for enhanced recovery and improved analgesia following breast cancer surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years of age\n* ASA I-II-III risk groups\n* Patients with informed consent\n* Patients undergoing breast cancer surgery\n\nExclusion Criteria: • Ages \\<18 and \\>65\n\n* ASA ≥ IV\n* History of allergy to local anesthetics\n* Known coagulation disorders\n* Infection near the insertion site\n* Chronic analgesic use\n* Patients with diabetes mellitus and those receiving neoadjuvant chemotherapy (due to potential impairment of pain sensation)\n* Body mass index \\>30\n* Dementia or confusion\n* Lack of cooperation'}, 'identificationModule': {'nctId': 'NCT07246720', 'briefTitle': 'IPP-PSP Block vs. SPSIPB in Breast Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Zonguldak Bulent Ecevit University'}, 'officialTitle': 'Interpectoral-pectoserratus Plane Block vs. Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Patients Undergoing Breast Cancer Surgery', 'orgStudyIdInfo': {'id': '2025/16-9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group IPP-PSP', 'description': 'Interpectoral-Pectoserratus Plane Block', 'interventionNames': ['Procedure: Interpectoral-Pectoserratus Plane Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group SPSIPB', 'description': 'Serratus Posterior Superior Intercostal Plane Block', 'interventionNames': ['Procedure: Serratus Posterior Superior Intercostal Plane Block']}], 'interventions': [{'name': 'Interpectoral-Pectoserratus Plane Block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided injection between pectoralis major-minor and pectoralis minor-serratus anterior planes.', 'armGroupLabels': ['Group IPP-PSP']}, {'name': 'Serratus Posterior Superior Intercostal Plane Block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided injection between the serratus posterior superior muscle and the intercostal muscles.', 'armGroupLabels': ['Group SPSIPB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67600', 'city': 'Zonguldak', 'state': 'Kozlu', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hande aydemir, prof.dr', 'role': 'CONTACT', 'email': 'hande.aydemir@beun.edu.tr', 'phone': '+90 372 261 23 00'}], 'facility': 'Zonguladk Bulent ecevit University', 'geoPoint': {'lat': 41.45139, 'lon': 31.79305}}], 'centralContacts': [{'name': 'çağdaş baytar, MD', 'role': 'CONTACT', 'email': 'cagdasbaytar31@gmail.com', 'phone': '+905542255960'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zonguldak Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'Çağdaş Baytar', 'investigatorAffiliation': 'Zonguldak Bulent Ecevit University'}}}}