Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:43 PM
Study NCT ID:
NCT04859803
Status:
COMPLETED
Last Update Posted:
2023-12-12
First Post:
2021-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rhomboid Intercostal and Sub-serratus Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'double'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2021-04-22', 'lastUpdatePostDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphine consumption', 'timeFrame': '24 hours', 'description': 'Postoperative morphine consumption'}], 'secondaryOutcomes': [{'measure': 'recovery time', 'timeFrame': '1 hour', 'description': 'The time from stopping anaesthetic agent until extubation'}, {'measure': 'Pain evaluation', 'timeFrame': '24 hous', 'description': 'Pain evaluation using the visual analog scale score,, 0= pain , 10= sever pain'}, {'measure': 'time to first analgesia', 'timeFrame': '24 hous', 'description': 'duration of block'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhomboid Intercostal Block']}, 'descriptionModule': {'briefSummary': 'The rhomboid intercostal block (RIB) can provide good analgesia effects after thoracic surgery . The ultrasound-guided RIB is novel analgesic techniques recently described by Elsharkawy et al. . Additionally, the RISS block anesthetizes the lateral cutaneous branches of the thoracic intercostal nerves and can be used in multiple clinical settings for chest wall and upper abdominal analgesia. However, the analgesic effects of the RISS block after breast surgery have not been analyzed through a randomized-controlled trial.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria Adult patients between 18-50 years. ASA physical status I and II Male gender\n\nExclusion criteria Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding disorders Use of any anti-coagulants Inability to provide informed consent ASA III-IV\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04859803', 'briefTitle': 'Rhomboid Intercostal and Sub-serratus Block', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of Rhomboid Intercostal Block With Sub-serratus Block on Perioperative Analgesia in Patients Undergoing Gynecomastia Surgery', 'orgStudyIdInfo': {'id': 'N-30-2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RISS group', 'description': 'patients will receive rhomboid intercostal block under ultrasound guidance.', 'interventionNames': ['Procedure: Patients will be received rhomboid intercostal block under ultrasound guidance.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients will received the conventional intravenous analgesia', 'interventionNames': ['Drug: conventional intravenous analgesia']}], 'interventions': [{'name': 'Patients will be received rhomboid intercostal block under ultrasound guidance.', 'type': 'PROCEDURE', 'description': 'Following endotracheal intubation, patients allotted to the RIB group were positioned in the lateral decubitus position with the chest on the operating side lying superiorly. The ipsilateral arm was abducted from the chest to move the scapula laterally. The RIB was performed as described previously \\[8\\]. A high-frequency (6-12 MHz) linear ultrasound probe (LOGIQ e ultrasonic system, Deutschland GmbH \\& Co. KG, Solingen, Germany) was placed medial to the medial border of the scapula in the oblique sagittal plane. The landmarks, i.e., the trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung, were identified in the ultrasound. Under aseptic conditions, an 80-mm 21-gauge needle was inserted at the level of T6-7 in the ultrasound view. A single dose of 30 ml 0.25% bupivacaine will be injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography.', 'armGroupLabels': ['RISS group']}, {'name': 'conventional intravenous analgesia', 'type': 'DRUG', 'description': 'Following endotracheal intubation, patients will be received morphine sulfate (0.02 mg/kg) bolus doses were used to preserve MAP and HR within 20% of pre-induction readings', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11451', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Cairo University.', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'still work'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amr Samir Wahdan', 'investigatorAffiliation': 'Cairo University'}}}}