Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 9:45 AM
Study NCT ID:
NCT06319859
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2024-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries
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': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-29', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-13', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first analgesic requirement', 'timeFrame': '48 hours post-operatively', 'description': 'The time to first analgesic required by the patient will be recorded'}], 'secondaryOutcomes': [{'measure': 'Nalbuphine consumption', 'timeFrame': '48 hours post-operatively', 'description': 'The amount of nalbuphine consumption as postoperative analgesia'}, {'measure': 'Postoperative pain', 'timeFrame': 'at 2, 4,8,12,18,24,30,36,42, and 48 hours post-operatively', 'description': "Postoperative pain at rest and movement by numeric rating scale Patients will be asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'"}, {'measure': 'The incidence of other adverse effects', 'timeFrame': '14 days post-operatively', 'description': 'The incidence of other adverse effects e.g. neurotoxicity, respiratory depression, nausea, vomiting, urine retention and pruritus will be recorded'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of intrathecal non-preservative-free morphine and its effect on pain in patients undergoing unilateral inguinal hernia surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-65 years old.\n* Both genders.\n* ASA I and II class.\n\nExclusion Criteria:\n\n* Patient refusal.\n* Known local anesthetic (LA) allergy.\n* Skin lesions or infections at the site of needle insertion.\n* Contraindications to spinal anesthesia.\n* Failure of spinal anesthesia.\n* ASA III and VI class.\n* Central or peripheral neuropathies.\n* Severe respiratory or cardiac diseases.'}, 'identificationModule': {'nctId': 'NCT06319859', 'briefTitle': 'Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Intrathecal Non-preservative-free Morphine With Bupivacaine Versus Intrathecal Bupivacaine Alone for Analgesia in Unilateral Inguinal Hernia Repair Surgeries: A Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'N-72-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'patients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally', 'interventionNames': ['Drug: Morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'patients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Morphine', 'type': 'DRUG', 'description': 'The patients will receive 0.1 mg morphine with 15 mg heavy bupivacaine intrathecally', 'armGroupLabels': ['Group A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The patients will receive 15 mg heavy bupivacaine with 0.1 ml saline intrathecally', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alaini hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anaesthesia', 'investigatorFullName': 'AbdElKhalik Mahmoud Shaban', 'investigatorAffiliation': 'Cairo University'}}}}