Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-27 @ 9:04 AM
Study NCT ID:
NCT06502067
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Serratus Posterior Intercostal Plane Block for Analgesia and Inflammatory Marker in Breast Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-22', 'studyFirstSubmitDate': '2024-07-06', 'studyFirstSubmitQcDate': '2024-07-14', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'is to calculate total perioperative analgesia consumption throughout (24hours).', 'timeFrame': '24 hour postoperative'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breastcancer', 'Perioperative Pain', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'To study the efficiacy of serratus posterior superior block in controlling perioperative breast cancer surgery pain and its effect on inflamatory markers.', 'detailedDescription': 'Back ground The presence of pain during the initial course of treatment in women with early-stage breast cancer was associated with significantly higher levels of c-reactive protein(CRP) ,interleukin-7(IL-7)and interleukin-13(IL-13) There is evidence of effectiveness of regional block in controlling inflamatory markers Serratus posterior superior intercostal plane block (SPSIPB) is a novel Regional technique that provides analgesia in the hemithorax, shoulder, and back of the neck which proved its efficacy in controlling pain after Video assisted thoracoscopic surgery there are little epidemiological data on (SPSIPB)usage in masectomy and lumpectomy procedures and its effect on inflamatory markers\n\nMethodology:\n\n* Type of the Study: Randomized prospective comparative controlled double-blinded study\n\n * Study Setting: Ain Shams University Hospitals\n * Study Period: One year after approval of the protocol.\n * Place :Ain shams university hospitals\n * Study Population: Adult patients who will undergo breast cancer surgey.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults undergoing unilateral breast surgery under general anesthesia\n* Age 21 to 60 years with body mass index (BMI)=18 to 25 kg/m2\n* American Society of Anesthesiologists (ASA) grade I-III.\n\nExclusion Criteria:\n\n* Patients with Long-time use of analgesic drugs\n* Past history of chest surgery,\n* Allergy to local anesthetics,\n* Systemic infection,\n* Cognitive and language disorders precluding participation,\n* Patients with coagulopathy,anticoagulant users\n* hemodynamic unstable patients\n* Patients with neurology, spinal, psychiatry diseases\n* infection at block site\n* patients refused to participate in the study .'}, 'identificationModule': {'nctId': 'NCT06502067', 'briefTitle': 'Efficacy of Serratus Posterior Intercostal Plane Block for Analgesia and Inflammatory Marker in Breast Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Perioperative Analgesia and Inflamatory Markers in Breast Surgery', 'orgStudyIdInfo': {'id': 'MD94/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'will receive serratus posterior superior block using bupivacaine', 'description': 'between the SPSM and the 3rd rib after using a test dose of 1- 2 mL saline and Following hydro-dissection,30ml 0.25%bupivacaine will be injected.', 'interventionNames': ['Drug: Analgesia mangement group A,B']}, {'type': 'OTHER', 'label': 'Arm B: (control group) patients will only receive general anesthesia without block.', 'description': 'Narcotic postoperative', 'interventionNames': ['Drug: Analgesia mangement group A,B']}], 'interventions': [{'name': 'Analgesia mangement group A,B', 'type': 'DRUG', 'description': '1gm of paracetamol, 30mg of ketorolac and 1mg Granitryl will be given twenty minutes before the end of the operation .', 'armGroupLabels': ['Arm B: (control group) patients will only receive general anesthesia without block.', 'will receive serratus posterior superior block using bupivacaine']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dalia Mostafa Ghazy, Master degree', 'role': 'CONTACT', 'email': 'daliaibrahimghazy@med.asu.edu.eg', 'phone': '01060192709'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}