Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT07040618
Status:
RECRUITING
Last Update Posted:
2025-06-27
First Post:
2025-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rhomboid Intercostal Block vs Erector Spinae Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a parallel-group randomized controlled trial comparing the effectiveness of two ultrasound-guided regional anesthesia techniques-Rhomboid Intercostal Block (RIB) and Erector Spinae Plane Block (ESPB)-in managing postoperative pain in lung cancer patients undergoing thoracotomy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24-hour postoperative morphine consumption', 'timeFrame': 'Within the first 24 hours postoperatively', 'description': 'This outcome measures the total amount of morphine (in milligrams) administered to each patient within the first 24 hours after thoracotomy. Morphine will be given as rescue analgesia when the patient reports a visual analog scale (VAS) pain score of 4 or more. The cumulative dose will be recorded and compared between the Rhomboid Intercostal Block (RIB) and Erector Spinae Plane Block (ESPB) groups to evaluate the relative effectiveness of each regional anesthesia technique in managing postoperative pain.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/11394926/', 'label': 'The morbidity, time course and predictive factors for persistent post-thoracotomy pain'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/19854794/', 'label': 'In patients undergoing thoracic surgery is paravertebral block as effective as epidural analgesia for pain management?'}]}, 'descriptionModule': {'briefSummary': 'This randomized trial compares rhomboid intercostal block (RIB) and erector spinae plane block (ESPB) for postoperative pain control in lung cancer patients undergoing thoracotomy. Sixty patients will be assessed for 24-hour morphine consumption, pain scores, hemodynamics, recovery time, satisfaction, and side effects. The study aims to identify the more effective technique for enhancing recovery and minimizing opioid use.', 'detailedDescription': 'This randomized clinical trial aims to evaluate the analgesic efficacy of two ultrasound-guided regional anesthesia techniques-Rhomboid Intercostal Block (RIB) and Erector Spinae Plane Block (ESPB)-in female lung cancer patients undergoing thoracotomy at the National Cancer Institute, Cairo University. Thoracotomy is known for causing severe postoperative pain, which, if not effectively managed, can lead to chronic pain and impaired pulmonary function. Traditional techniques like thoracic epidural or paravertebral blocks, while effective, have limitations due to technical complexity and potential complications. Recently, interfascial plane blocks such as ESPB have shown promise for thoracic analgesia, and RIB has emerged as a technique potentially offering superior lateral thoracic wall coverage.\n\nSixty patients will be randomly assigned to receive either RIB or ESPB 30-45 minutes before surgery. The primary outcome is 24-hour postoperative morphine consumption. Secondary outcomes include visual analog scale (VAS) pain scores, hemodynamic stability, time to first analgesic request, recovery duration, patient satisfaction, and incidence of nausea and vomiting.\n\nGeneral anesthesia will be standardized across both groups. Data will be analyzed using appropriate statistical tests, and ethical approval will be obtained prior to patient enrollment. This study supports multimodal analgesia and aims to inform clinical practice in pain management after oncologic thoracic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing thoracotomy for lung cancer\n\nAge ≥ 18 years and ≤ 65 years\n\nASA physical status II or III\n\nBody Mass Index (BMI) \\> 20 kg/m² and \\< 35 kg/m²\n\nWilling and able to provide informed consent\n\nExclusion Criteria:\n\nPatient refusal\n\nASA physical status IV\n\nAge \\< 18 years or \\> 65 years\n\nBMI \\< 20 kg/m² or \\> 35 kg/m²\n\nKnown allergy or contraindication to local anesthetics or opioids used in the study\n\nHistory of chronic pain or psychological disorders\n\nContraindications to regional anesthesia (e.g., local infection, coagulopathy, pre-existing peripheral neuropathy)\n\nSevere respiratory, cardiac, hepatic, or renal disease\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07040618', 'acronym': 'RIB-ESPB', 'briefTitle': 'Rhomboid Intercostal Block vs Erector Spinae Block', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Assessing the Effectiveness of Rhomboid Intercostal and Erector Spinae Plane Blocks After Lung Cancer Thoracotomy', 'orgStudyIdInfo': {'id': 'NCI-CAIRO-RIb-ESPB-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound-guided Rhomboid Intercostal Block', 'description': 'Patients in this group will receive a rhomboid intercostal block with 20-25 mL of 0.25% bupivacaine injected between the rhomboid major and intercostal muscles under ultrasound guidance 30-45 minutes before surgery.', 'interventionNames': ['Procedure: Ultrasound-guided Rhomboid Intercostal Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound-guided Erector Spinae Plane Block', 'description': 'Patients in this group will receive an erector spinae plane block with 20-25 mL of 0.25% bupivacaine injected deep to the erector spinae muscle at the T4-T5 level under ultrasound guidance 30-45 minutes before surgery.', 'interventionNames': ['Procedure: Ultrasound-guided Erector Spinae Plane Block']}], 'interventions': [{'name': 'Ultrasound-guided Rhomboid Intercostal Block', 'type': 'PROCEDURE', 'description': 'This intervention involves an ultrasound-guided injection of 20-25 mL of 0.25% bupivacaine into the fascial plane between the rhomboid major and intercostal muscles. The patient is positioned laterally, and the block is performed at the T5-T6 level using a high-frequency linear ultrasound probe. The goal is to anesthetize the lateral cutaneous branches of the intercostal nerves to provide postoperative thoracic analgesia.', 'armGroupLabels': ['Ultrasound-guided Rhomboid Intercostal Block']}, {'name': 'Ultrasound-guided Erector Spinae Plane Block', 'type': 'PROCEDURE', 'description': 'This intervention consists of an ultrasound-guided injection of 20-25 mL of 0.25% bupivacaine into the plane deep to the erector spinae muscle at the T4-T5 transverse process level. The patient is positioned sitting or in lateral decubitus, and the procedure uses a curved or linear ultrasound probe. This block targets the dorsal and ventral rami of thoracic spinal nerves to manage postoperative pain after thoracotomy.', 'armGroupLabels': ['Ultrasound-guided Erector Spinae Plane Block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'National Cancer Institute - Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sayed M Abed, MD', 'role': 'CONTACT', 'email': 'sayed.abed@nci.cu.edu.eg', 'phone': '+20 122 680 6532'}], 'overallOfficials': [{'name': 'Sayed M Abed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Anesthesia and Pain Management, National Cancer Institute -- Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared due to institutional policy and privacy concerns. The study involves sensitive patient data from a cancer population, and data sharing may pose risks to confidentiality despite de-identification efforts. Access will remain restricted to the research team at the National Cancer Institute, Cairo University, in accordance with ethical approval and informed consent protocols.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Sayed Mahmoud Abed', 'investigatorAffiliation': 'Cairo University'}}}}