Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-25 @ 7:51 PM
Study NCT ID:
NCT06654635
Status:
RECRUITING
Last Update Posted:
2024-10-23
First Post:
2024-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Rhomboid Intercostal Plane Block Versus Thoracic Erector Spinae Plane Block in Upper Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine consumption', 'timeFrame': '24 hours postoperatively', 'description': 'Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates The visual analogue scale (VAS). ≥ 4 with maximum dose 20 mg for 24 hours. The total amount of morphine (mg) given will be recorded for the 3 groups.'}], 'secondaryOutcomes': [{'measure': 'Degree of pain', 'timeFrame': '24 hours postoperatively', 'description': 'Postoperative pain will be assessed by visual analogue scale (VAS) 30 min from admission to PACU, 2, 4, 6, 12, 18 and 24 h postoperative (0= no pain, 10= sever pain).'}, {'measure': 'Time to 1st request of rescue analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'Time to 1st request for the rescue of analgesia (time from the end of surgery till first dose of morphine administrated ) will be recorded.'}, {'measure': 'Heart rate', 'timeFrame': 'Every 15 min till the end of surgery', 'description': 'Heart rate will be measured preoperative, after induction, after receiving block and every 15 min till the end of surgery'}, {'measure': 'Mean arterial blood pressure', 'timeFrame': 'Every 15 min till the end of surgery', 'description': 'Mean arterial blood pressure will be measured preoperative, after induction, after receiving block and every 15 min till the end of surgery'}, {'measure': 'Incidence of side effects', 'timeFrame': '24 hours Postoperatively', 'description': 'Any undesirable adverse events will be treated and recorded (e.g., bradycardia, hypotension, pneumothorax, hematoma, nerve injury and nausea, vomiting, local anesthetic systemic toxicity (LAST), respiratory depression or any other complication).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasound', 'Rhomboid Intercostal Plane Block', 'Thoracic Erector Spinae Plane Block', 'Upper Abdominal Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of the work is to evaluate the analgesic efficacy of ultrasound guided rhomboid intercostal plane block versus ultrasound guided thoracic erector spinae block in patients undergoing upper abdominal surgery.', 'detailedDescription': 'Abdominal surgery is one of the most definitive and mainstay treatment options for abdominal pathologies in clinical practice. Acute postoperative pain is a major challenge in the postoperative period.\n\nThe improved safety and efficacy that ultrasound brings to regional anesthesia helped promote its use and realize the benefits that regional anesthesia has over general anesthesia, such as decreased morbidity and mortality, superior postoperative analgesia, cost-effectiveness, decrease postoperative complications and an improved postoperative course .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 21-65 years.\n* Both gender.\n* American Society of Anesthesiologists (ASA) classification I-II.\n* Presented for elective upper abdominal surgery.\n\nExclusion Criteria:\n\n* Patients refused to participate.\n* Patients with known or suspected allergy to the used medication.\n* Patients with preoperative chronic pain.\n* Patients with major cardiac, renal, respiratory, or hepatic disease.\n* Patients with potential risk of coagulopathy.\n* Obese patients with body mass index (BMI) \\>35.'}, 'identificationModule': {'nctId': 'NCT06654635', 'briefTitle': 'Ultrasound Guided Rhomboid Intercostal Plane Block Versus Thoracic Erector Spinae Plane Block in Upper Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparison Between Ultrasound Guided Rhomboid Intercostal Plane Block and Thoracic Erector Spinae Plane Block in Patients Undergoing Upper Abdominal Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '36264MD87/5/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rhomboid intercostal plane block group', 'description': 'The patients in this group will receive ultrasound -guided rhomboid intercostal plane block after induction of general anesthesia. The rhomboid intercostal block will be performed at the T6 levels, bilaterally.', 'interventionNames': ['Drug: Rhomboid intercostal plane block']}, {'type': 'EXPERIMENTAL', 'label': 'Erector spinae plane block group', 'description': 'The patients in this group will receive ultrasound -guided Erector spinae plane block after induction of general anesthesia. ESP block will be performed at the level of T9 bilaterally.', 'interventionNames': ['Other: Erector spinae plane block']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'No block will be performed, and patient will receive general anesthesia (GA) only.', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Rhomboid intercostal plane block', 'type': 'DRUG', 'description': 'The patients in this group will receive ultrasound -guided rhomboid intercostal plane block after induction of general anesthesia. The rhomboid intercostal block will be performed at the T6 levels, bilaterally.', 'armGroupLabels': ['Rhomboid intercostal plane block group']}, {'name': 'Erector spinae plane block', 'type': 'OTHER', 'description': 'The patients in this group will receive ultrasound -guided Erector spinae plane block after induction of general anesthesia. Erector spinae plane block will be performed at the level of T9 bilaterally.', 'armGroupLabels': ['Erector spinae plane block group']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'No block will be performed, and patient will receive general anesthesia (GA) only.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Omima M Eldeeb, Master', 'role': 'CONTACT', 'email': 'omima.eldeeb@med.tanta.edu.eg', 'phone': '01004584669'}, {'name': 'Ayman A Yousef, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ghada F El Baradey, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Naglaa K Mohamed, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wail E Messbah, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Omima M Eldeeb, Master', 'role': 'CONTACT', 'email': 'omima.eldeeb@med.tanta.edu.eg', 'phone': '01004584669'}]}, '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': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Omima Mohammed Fakher Eldin Ali', 'investigatorAffiliation': 'Tanta University'}}}}