Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT06653803
Status:
RECRUITING
Last Update Posted:
2025-08-21
First Post:
2024-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rhomboid Intercostal Block Versus Retrolaminar Block for Postoperative Analgesia After Thoracoscopic Sympathectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-21', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)', 'timeFrame': '24 hours after the end of surgery', 'description': 'The time interval between the block performance and the first request of postoperative analgesia'}], 'secondaryOutcomes': [{'measure': 'Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)', 'timeFrame': '24 hours after the end of surgery', 'description': 'NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (At PACU, 1h, 3h, 6h, 12h, 18h, 24h) after the end of surgery'}, {'measure': 'Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)', 'timeFrame': '24 hours after the end of surgery', 'description': 'The total dose of the rescue analgesic consumed in the first 24 hours after the end of surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rhomboid Intercostal Block', 'Retrolaminar Block', 'Regional Analgesia'], 'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': "Background: Although thoracoscopic sympathectomy is made via small incisions, it is associated with severe postoperative pain. Both Rhomboid intercostal block (RIB) and Retrolaminar block (RLB) are recent techniques used for pain control after such procedures\n\nObjectives: To compare the effectiveness of RIB and RLB in providing postoperative analgesia after thoracoscopic sympathectomy in adult patients and their impact on the patient's outcomes.\n\nPatients and Methods: This prospective, randomized (1:1), double-blind clinical trial; will be carried out on 60 patients scheduled for elective thoracoscopic sympathectomy under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group A; general anesthesia with intraoperative ipsilateral ultrasound-guided RIB, whereas in group B; general anesthesia with intraoperative ipsilateral ultrasound-guided RLB."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status ≤ II\n* Age from 18 to 60 years\n* Body Mass Index (BMI) \\< 35 kg/m²\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status \\> II\n* Age \\< 18 years or \\> 60 years\n* Body Mass Index (BMI) ≥ 35\n* Local infection at the puncture site\n* Altered mental status\n* Pregnant women\n* Allergy to study drugs\n* Chronic pain\n* Coagulation abnormalities or on anticoagulants\n* Severe hepatic or kidney disease'}, 'identificationModule': {'nctId': 'NCT06653803', 'briefTitle': 'Rhomboid Intercostal Block Versus Retrolaminar Block for Postoperative Analgesia After Thoracoscopic Sympathectomy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Damanhour Teaching Hospital'}, 'officialTitle': 'Ultrasound-guided Rhomboid Intercostal Block Versus Retrolaminar Block for Postoperative Analgesia After Thoracoscopic Sympathectomy: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'DTH: 24001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A (n=30)', 'description': 'Rhomboid Intercostal Block', 'interventionNames': ['Procedure: Rhomboid Intercostal Block (RIB)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (n=30)', 'description': 'Retrolaminar Block', 'interventionNames': ['Procedure: Retrolaminar Block (RLB)']}], 'interventions': [{'name': 'Rhomboid Intercostal Block (RIB)', 'type': 'PROCEDURE', 'description': 'Intraoperative Ipsilateral Ultrasound-guided RIB', 'armGroupLabels': ['Group A (n=30)']}, {'name': 'Retrolaminar Block (RLB)', 'type': 'PROCEDURE', 'description': 'Intraoperative Ipsilateral Ultrasound-guided RLB', 'armGroupLabels': ['Group B (n=30)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damanhūr', 'state': 'El-Beheira', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed M Shaat, MD', 'role': 'CONTACT', 'email': 'ahmedshaat99@gmail.com', 'phone': '00201223482709'}], 'facility': 'Damanhour Teaching Hospital', 'geoPoint': {'lat': 27.38333, 'lon': 30.95}}], 'centralContacts': [{'name': 'Ahmed M Shaat, MD', 'role': 'CONTACT', 'email': 'ahmedshaat99@gmail.com', 'phone': '00201223482709'}], 'overallOfficials': [{'name': 'Ahmed M Shaat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Damanhour Teaching Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damanhour Teaching Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}