Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 11:31 PM
Study NCT ID:
NCT04609033
Status:
COMPLETED
Last Update Posted:
2021-08-30
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D009020', 'term': 'Morphine'}, {'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'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'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-27', 'studyFirstSubmitDate': '2020-09-03', 'studyFirstSubmitQcDate': '2020-10-23', 'lastUpdatePostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative level of ACTH hormone', 'timeFrame': '6 hours', 'description': 'a stress marker that increase with pain and surgery'}], 'secondaryOutcomes': [{'measure': 'VISUUEAL ANALOGE SCORE', 'timeFrame': '24 hours', 'description': 'to assess postoperative pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perioperative Pain']}, 'descriptionModule': {'briefSummary': 'Postoperative abdominal and shoulder pain that are experienced in patients undergoing laparoscopic cholecystectomy (LC) is significant. Although it is generally less sever than post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours postoperatively', 'detailedDescription': 'The incidence of pain after laparoscopy may be as high as 36 to 63 percent and is attributed to the carbon dioxide gas (CO2) used to induce pneumo-peritoneum1.\n\nThe residual part of CO2 remains in the peritoneal cavity for several days after the operation and causes stretching of the phrenic nerve endings, local hypothermia, and diaphragmatic irritation by carbonic acid formation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for Laparoscopic cholecystectomy.\n* Age spectrum of 18 - 55 years\n* ASA I, II\n* Have no comorbid chronic medical diseases\n\nExclusion Criteria:\n\n* Patients with co morbid medical diseases\n* Age outside the specified range\n* Acute inflammation of the gall bladder\n* Critically ill patient\n* Emergency operations\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT04609033', 'briefTitle': 'Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': '17300477'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine group', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine + morphine', 'interventionNames': ['Drug: Bupivacaine + morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine + morphine + ketamine', 'interventionNames': ['Drug: Bupivacaine + morphine + ketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'isotonic saline', 'interventionNames': ['Drug: isotonic saline']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'instillation of local anaesthetic in the abdominal cavity at the end of the procedure', 'armGroupLabels': ['bupivacaine group']}, {'name': 'isotonic saline', 'type': 'DRUG', 'description': 'instillation of local anaesthetic in the abdominal cavity at the end of the procedure', 'armGroupLabels': ['isotonic saline']}, {'name': 'Bupivacaine + morphine', 'type': 'DRUG', 'description': 'instillation of local anaesthetic + morphine sulfate in the abdominal cavity at the end of the procedure', 'armGroupLabels': ['bupivacaine + morphine']}, {'name': 'Bupivacaine + morphine + ketamine', 'type': 'DRUG', 'description': 'instillation of local anaesthetic + morphine sulfate + ketamine in the abdominal cavity at the end of the procedure', 'armGroupLabels': ['bupivacaine + morphine + ketamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University Hospitals', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'consultant', 'investigatorFullName': 'Esam Hamed', 'investigatorAffiliation': 'Assiut University'}}}}