Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-30 @ 8:21 PM
Study NCT ID:
NCT06882369
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-18
First Post:
2025-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TAP Block , Intrathecal Morphine Or Their Combination For Post Operative Analgesia Following TAH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2025-03-07', 'studyFirstSubmitQcDate': '2025-03-12', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first analgesic request', 'timeFrame': '24 hours', 'description': 'Time (in hours) until the patient demand additional analgesia.'}], 'secondaryOutcomes': [{'measure': 'Total analgesic consumption', 'timeFrame': '24 hours', 'description': 'Cumulative postoperative analgesic consumption'}, {'measure': 'Time to ambulation', 'timeFrame': '24 hours', 'description': 'Time (in hours) from arrival in the PACU until the patient was able to walk.'}, {'measure': 'complications', 'timeFrame': '24 hours', 'description': 'Incidence of nausea, vomiting, pruritus, respiratory depression, hematoma, infection or hemodynamic instability'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-operative Pain Management']}, 'descriptionModule': {'briefSummary': 'This randomized controlled clinical trial designed to evaluate the efficacy of transversus abdominis plane (TAP) block, intrathecal morphine, or their combination in postoperative pain relief, as assessed by time to first analgesic request, pain scores, total postoperative analgesic consumption, time of ambulation, complications and hemodynamics following total abdominal hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients aged 30 to 70 years.\n* Elective total abdominal hysterectomy.\n* ASA physical status I or II.\n* Willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Refusal of the block.\n* Allergy to study medications.\n* Preexisting coagulation disorders.\n* Local infection at the site of needle insertion.\n* Uncontrolled respiratory or cardiac disorders.\n* Impaired kidney or liver function.'}, 'identificationModule': {'nctId': 'NCT06882369', 'briefTitle': 'TAP Block , Intrathecal Morphine Or Their Combination For Post Operative Analgesia Following TAH', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Efficacy Of Transversus Abdominis Plane Block , Intrathecal Morphine Or Their Combination For Post Operative Analgesia Following Total Abdominal Hysterectomy.', 'orgStudyIdInfo': {'id': 'TAP vs. morphine vs. both'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TAP block', 'description': 'Bilateral ultrasound-guided TAP block with 20 mL of 0.25% plain bupivacaine on each side of the abdomen at the end of surgery.', 'interventionNames': ['Procedure: TAP Block', 'Drug: spinal anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intrathecal Morphine', 'description': 'Intrathecal injection of 100 µg morphine plus 20 mg hyperbaric bupivacaine (in spinal anesthesia).', 'interventionNames': ['Drug: Intrathecal morphine injection', 'Drug: spinal anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combined', 'description': 'Intrathecal injection of 50 µg morphine plus 20 mg hyperbaric bupivacaine combined with bilateral ultrasound-guided TAP block using 20 mL of 0.25% plain bupivacaine on each side of the abdomen at the end of surgery.', 'interventionNames': ['Procedure: TAP Block', 'Drug: Intrathecal morphine injection', 'Drug: spinal anesthesia']}], 'interventions': [{'name': 'TAP Block', 'type': 'PROCEDURE', 'description': 'The transabdominal plane (TAP) block is a regional anesthesia technique used for postoperative pain management in abdominal wall procedures, providing somatic analgesia to the anterior and lateral abdominal walls', 'armGroupLabels': ['Combined', 'TAP block']}, {'name': 'Intrathecal morphine injection', 'type': 'DRUG', 'description': 'Intrathecal injection of morphine plus 20 mg hyperbaric bupivacaine in spinal anesthesia', 'armGroupLabels': ['Combined', 'Intrathecal Morphine']}, {'name': 'spinal anesthesia', 'type': 'DRUG', 'description': 'intrathecal injection of bupivacaine', 'armGroupLabels': ['Combined', 'Intrathecal Morphine', 'TAP block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'state': 'Minya Governorate', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'sohair Adeeb, assist.prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minia University, faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Islam Ahmed Bakr Mohammed', 'investigatorAffiliation': 'Minia University'}}}}