Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 3:54 AM
Study NCT ID:
NCT07367568
Status:
RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-24', 'studyFirstSubmitDate': '2026-01-17', 'studyFirstSubmitQcDate': '2026-01-17', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine consumption', 'timeFrame': '24 hours postoperatively', 'description': 'If the numeric rating scale (NRS) is ≥ 4, an IV morphine dose (3 mg) will be provided Paracetamol 1 gm and ketorolac 30 mg will be administered every 8 hours postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Degree of pain', 'timeFrame': '48 hours postoperatively', 'description': 'Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS score will be recorded in post-anesthesia care unit (PACU) then at 1, 6, 12, 18, 24, and 48 hours postoperatively.'}, {'measure': 'Time to first request of rescue analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'Time to first request of rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.'}, {'measure': 'Intraoperative fentanyl consumption', 'timeFrame': 'Intraoperatively', 'description': 'Intraoperative fentanyl consumption will be recorded.'}, {'measure': 'Mean arterial pressure', 'timeFrame': '4 hours postoperatively', 'description': 'Mean arterial pressure will be recorded immediately before induction of anesthesia, 15 min after performing the block incision and at 20-minute intervals intraoperatively, and then hourly till 4 hours postoperatively.'}, {'measure': 'Heart rate', 'timeFrame': '4 hours postoperatively', 'description': 'Heart rate will be recorded immediately before induction of anesthesia, 15 min after performing the block incision and at 20-minute intervals intraoperatively, and then hourly till 4 hours postoperatively.'}, {'measure': 'Incidence of adverse effects', 'timeFrame': '24 hours postoperatively', 'description': 'Incidence of adverse effects such as nausea, vomiting, hypotension, and bradycardia, pneumothorax, local anesthetic toxicity for up to 24 hours post-surgery will be documented.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Costotransverse Foramen Block', 'Erector Spinae Plane Block', 'Modified Radical Mastectomy']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the costotransverse foramen block with erector spinae plane block in modified radical mastectomy.', 'detailedDescription': 'Postoperative pain following modified radical mastectomy (MRM) is a considerable consequence, impacting the ipsilateral upper limbs, axillae, and thorax, resulting in diminished functional ability and substantial economic and societal repercussions.\n\nErector spinae plane block (ESPB), an interfascial block, minimizes nerve and vessel injury by allowing local anesthetics to diffuse across relevant spaces; it is technically simpler and has shown benefits in reducing postoperative analgesic use and pain scores.\n\nA novel technique, the costotransverse foramen block (CTFB), is one type of Inter-transverse process (ITP) blocks. This technique entails the anterior dispersion of the local anesthetic injectate into the paravertebral region, affecting the thoracic nerve at the injection site and neighboring levels, while exhibiting negligible posterior diffusion of dye to the deep back muscles'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Females scheduled for modified radical mastectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult females \\> 18 years and ≤ 65 years old.\n* American Society of Anesthesiologists (ASA) physical status П-III.\n* Body mass index (BMI) 18-35 kg/m2.\n* Scheduled for modified radical mastectomy.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to local anesthetic agents.\n* Active infection at the injection site (e.g., cellulitis, abscess).\n* Coagulopathy or ongoing anticoagulant/antiplatelet therapy \\[International Normalized Ratio (INR) \\> 1.5 or platelet count \\< 100,000/µL\\].\n* Severe respiratory, cardiac, hepatic, or renal disease.\n* Morbid obesity.\n* Severe cognitive impairment or uncooperative behavior that could interfere with block placement.'}, 'identificationModule': {'nctId': 'NCT07367568', 'briefTitle': 'Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Comparison of Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AP2509-501-124-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CTFB Group', 'description': 'Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%.', 'interventionNames': ['Other: Costotransverse foramen block']}, {'type': 'EXPERIMENTAL', 'label': 'ESPB Group', 'description': 'Patients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.', 'interventionNames': ['Other: Erector spinae plane block']}], 'interventions': [{'name': 'Costotransverse foramen block', 'type': 'OTHER', 'description': 'Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%.', 'armGroupLabels': ['CTFB Group']}, {'name': 'Erector spinae plane block', 'type': 'OTHER', 'description': 'Patients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.', 'armGroupLabels': ['ESPB Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mai M Elrawas, MD', 'role': 'CONTACT', 'email': 'mai.elrawas@nci.cu.edu.eg', 'phone': '00201222177242'}], 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mai M Elrawas, MD', 'role': 'CONTACT', 'email': 'mai.elrawas@nci.cu.edu.eg', 'phone': '00201222177242'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of Anaesthesia, Intensive Care and Pain Management, National Cancer Institute, Cairo University Cairo University, Cairo, Egypt.', 'investigatorFullName': 'Mai Mohamed El Rawas', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}