Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT06088420
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2023-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analgesic Efficacy of Different Nerve Blocks in Postoperative Cesarean Section
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-06', 'studyFirstSubmitDate': '2023-10-10', 'studyFirstSubmitQcDate': '2023-10-15', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of analgesia until first analgesic request.', 'timeFrame': '24 hours .', 'description': 'the time interval from immediate postoperative period until NRS reached 4'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'comparing analgesic efficacy of different nerve blocks on post operative cesarean sections.', 'detailedDescription': 'Analgesic efficacy of Erector Spinae, Quadratus Lumborum and Intrathecal Morphine for post operative pain relief after cesarean section,'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-40 years old\n* more or equal 37 weeks of gestation\n* ASA 1,2\n* Elective cesarean delivery\n\nExclusion Criteria:\n\n* Patient refusal\n* inability to cooperate with or understand the study\n* local infection.\n* bleeding disorder\n* known anaphylaxis to any drug used in the trial\n* ASA physical status more than 2\n* emergency operations\n* chronic opioid use (opioid use in the past 3 months)\n* Neurologic deficit or disorder\n* contraindication to regional anesthesia.'}, 'identificationModule': {'nctId': 'NCT06088420', 'briefTitle': 'Analgesic Efficacy of Different Nerve Blocks in Postoperative Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Analgesic Efficacy of Erector Spinae Block , Quadratus Lumborum Block, and Intrathecal Morphine for Postoperative Pain Relief After Cesarean Section: A Randomized Study', 'orgStudyIdInfo': {'id': '17101962'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intrathcal Morphine Group', 'description': 'Intrathecal morphine administration for post operative pain relief after cesarean section', 'interventionNames': ['Procedure: Intrathcal Morphine Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Quadratus Lumborum nerve block group', 'description': 'Quadratus Lumborum nerve block administration for post operative pain relief after cesarean section', 'interventionNames': ['Procedure: Quadratus Lumborum nerve block(QL) group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erector Spinae nerve block group', 'description': 'Erector Spinae nerve block administraion for post operative pain relief after cesarean section', 'interventionNames': ['Procedure: Erector Spinae nerve block (ESP)group']}], 'interventions': [{'name': 'Intrathcal Morphine Group', 'type': 'PROCEDURE', 'description': 'intrathecal morphine (150 μg) in addition to standard spinal anesthetic drugs(10-12 mg 0.5% hyperbaric bupivacaine)', 'armGroupLabels': ['Intrathcal Morphine Group']}, {'name': 'Quadratus Lumborum nerve block(QL) group', 'type': 'PROCEDURE', 'description': 'intrathecal morphine (150 μg) in addition to standard spinal anesthetic drugs (10-12 mg 0.5% hyperbaric bupivacaine) + bilateral QL block by injecting 20 ml of 0.25% isobaric bupivacaine bolus with 4 mg ) dexamethasone as an adjuvant', 'armGroupLabels': ['Quadratus Lumborum nerve block group']}, {'name': 'Erector Spinae nerve block (ESP)group', 'type': 'PROCEDURE', 'description': 'intrathecal morphine (150 μg) in addition to standard spinal anesthetic drugs (10-12 mg 0.5% hyperbaric bupivacaine) + bilateral ESP block by injecting 20 ml of 0.25% isobaric bupivacaine bolus with 4 mg ) dexamethasone as an adjuvant', 'armGroupLabels': ['Erector Spinae nerve block group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'state': 'Manfalout', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ghada Abo Elfadl, prof', 'role': 'CONTACT', 'email': 'ghadafadl77@gmail.com', 'phone': '01005802086'}], 'facility': 'Mahmoud Mamdouh Ekram', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Ghada Abo Elfadl, MD', 'role': 'CONTACT', 'email': 'ghadafadl77@gmail.com', 'phone': '01005802086'}, {'name': 'Ghada Abo Elfadl', 'role': 'CONTACT', 'email': 'ghadafadl77@gmail.com', 'phone': '01005802086'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator.', 'investigatorFullName': 'Mahmoud Mamdouh Ekram', 'investigatorAffiliation': 'Assiut University'}}}}