Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-30 @ 9:15 AM
Study NCT ID:
NCT07012603
Status:
RECRUITING
Last Update Posted:
2025-06-11
First Post:
2025-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
External Oblique and Rectus Abdominis Plane (EXORA) Block for Postoperative Analgesia in Patients Undergoing Umbilical Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003766', 'term': 'Dental Occlusion'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2025-05-31', 'studyFirstSubmitQcDate': '2025-05-31', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine consumption', 'timeFrame': '24 hours postoperatively', 'description': 'Rescue analgesia of morphine will be given as 5 mg bolus if the numeric rating scale (NRS) \\> 3 to be repeated after 30 min if pain persists until the NRS \\< 4.'}], 'secondaryOutcomes': [{'measure': 'Time to the 1st rescue analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'Time to the first request for the rescue analgesia (time from the end of surgery to first dose of morphine administrated).'}, {'measure': 'Intraoperative fentanyl consumption', 'timeFrame': 'Intraoperatively', 'description': 'Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).'}, {'measure': 'Degree of pain', 'timeFrame': '24 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 will be assessed at post-anesthesia care unit (PACU), 2, 4, 6, 8, 12, and 24 h postoperatively.'}, {'measure': 'Mean arterial pressure', 'timeFrame': 'Till the end of surgery (Up to 2 hours)', 'description': 'Mean arterial pressure will be recorded preoperatively and every 30 minutes till the end of surgery.'}, {'measure': 'Heart rate', 'timeFrame': 'Till the end of surgery (Up to 2 hours)', 'description': 'Heart rate will be recorded preoperatively and every 30 minutes till the end of surgery.'}, {'measure': 'Incidence of adverse events', 'timeFrame': '24 hours postoperatively', 'description': 'Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['External Oblique and Rectus Abdominis Plane', 'Postoperative Analgesia', 'Umbilical Hernia Repair']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of the external oblique and rectus abdominis plane (EXORA) block for postoperative analgesia in patients undergoing umbilical hernia repair.', 'detailedDescription': 'Umbilical hernias account for approximately 6-14% of adult abdominal wall hernias. These hernias are typically acquired and are mainly caused by increased abdominal pressure. Umbilical hernias do not heal on their own and usually require surgical intervention.\n\nThe external oblique and rectus abdominis plane (EXORA) block is an emerging technique providing a sensory block to the anterolateral abdominal wall. The EXORA block involves local anaesthetic injection into the fascial plane between the external oblique and rectus abdominis muscles. This method provides better dermatomal coverage, making the EXORA block particularly effective in the treatment of somatic pain in the anterolateral area of the upper and middle abdomen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 65 years.\n* Both sexes.\n* American Society of Anesthesiology (ASA) physical status I-II.\n* Undergoing umbilical hernia repair.\n\nExclusion Criteria:\n\n* History of allergies to local anesthetics.\n* Bleeding or coagulation disorders.\n* Anatomical abnormalities.\n* Psychiatric and neurological disorders.\n* Local infection at the site of injection.\n* Complicated hernial defects \\[strangulated, incarcerated, or obstructed cases\\].'}, 'identificationModule': {'nctId': 'NCT07012603', 'briefTitle': 'External Oblique and Rectus Abdominis Plane (EXORA) Block for Postoperative Analgesia in Patients Undergoing Umbilical Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'External Oblique and Rectus Abdominis Plane (EXORA) Block for Postoperative Analgesia in Patients Undergoing Umbilical Hernia Repair: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '36264PR1207/5/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EXORA block group', 'description': 'Patients will receive an external oblique and rectus abdominis plane (EXORA) block using 20 mL of bupivacaine 0.25%.', 'interventionNames': ['Other: External oblique and rectus abdominis plane (EXORA) block']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': 'Patients will receive a sham block using 20 mL of normal saline as a control group.', 'interventionNames': ['Other: Sham block']}], 'interventions': [{'name': 'External oblique and rectus abdominis plane (EXORA) block', 'type': 'OTHER', 'description': 'Patients will receive an external oblique and rectus abdominis plane (EXORA) block using 20 mL of bupivacaine 0.25%.', 'armGroupLabels': ['EXORA block group']}, {'name': 'Sham block', 'type': 'OTHER', 'description': 'Patients will receive a sham block using 20 mL of normal saline as a control group.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31527', 'city': 'Tanta', 'state': 'El-Gharbia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohammed S Elsharkawy, MD', 'role': 'CONTACT', 'email': 'mselsharkawy@med.tanta.edu.eg', 'phone': '00201148207870'}, {'name': 'Saad A Moharam, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Mohammed S Elsharkawy, MD', 'role': 'CONTACT', 'email': 'mselsharkawy@med.tanta.edu.eg', 'phone': '00201148207870'}]}, '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': 'Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.', 'investigatorFullName': 'Mohammed Said ElSharkawy', 'investigatorAffiliation': 'Tanta University'}}}}