Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-03-21 @ 7:45 AM
Study NCT ID:
NCT06535256
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2024-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare Intraperitoneal Instillation of Bupivacaine+dexmedetomidine Versus Bupivacaine+dexamethasone on Postoperative Pain After Lap Cholecystectomy
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': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2024-07-25', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence and severity of postoperative pain for 24 hours', 'timeFrame': 'severity of postoperative pain measured at 1, 2, 4, 8, 16, and 24 hours. postoperatively, using Visual Analogue Scale', 'description': 'using VAS pain score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Comparison of intraperitoneal instillation of bupivacaine with dexmedetomidine versus bupivacaine with dexamethasone on postoperative pain after laparoscopic cholecystectomy', 'detailedDescription': 'Laparoscopy has become the preferred mode for many diagnostic and operative procedures. It has the advantage better cosmetic results, faster recovery, short post-operative hospital stays, and early resumption of normal activities. Post-laparoscopic pain results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity is very annoying to the patients.\n\nAlthough the severity of pain after a laparoscopic procedure is less compared to laparotomy, but it is acute and can lead to increased analgesic requirements and prolonged hospital stays.\n\nSeveral studies have evaluated post-laparoscopic pain relief methods such as intravenous analgesics analgesic patches, steroids, and intra-peritoneal instillation of local anaesthetics alone or with additives.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients scheduled for laparoscopic cholecystectomy\n* Age 18-60 years\n* American Society of Anesthesiologists (ASA) physical status I-II\n\nExclusion criteria:\n\n* Patients with diabetes mellitus\n* Allergy to the study drugs\n* Patients on steroids\n* Pregnant females\n* Patients with cardiac, pulmonary, hepatic or renal disorders'}, 'identificationModule': {'nctId': 'NCT06535256', 'briefTitle': 'Compare Intraperitoneal Instillation of Bupivacaine+dexmedetomidine Versus Bupivacaine+dexamethasone on Postoperative Pain After Lap Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Comparison of Intraperitoneal Instillation of Bupivacaine with Dexmedetomidine Versus Bupivacaine with Dexamethasone on Postoperative Pain After Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'Asw 917/5/24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine with dexamethasone', 'description': '40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline).', 'interventionNames': ['Combination Product: bupivacaine with dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'bupivacaine with dexmedetomidine', 'description': '40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml).', 'interventionNames': ['Combination Product: bupivacaine with dexmedetomidine']}], 'interventions': [{'name': 'bupivacaine with dexamethasone', 'type': 'COMBINATION_PRODUCT', 'description': 'intra-peritoneal instillation of bupivacaine with dexamethasone (received 40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline).', 'armGroupLabels': ['bupivacaine with dexamethasone']}, {'name': 'bupivacaine with dexmedetomidine', 'type': 'COMBINATION_PRODUCT', 'description': 'intra-peritoneal instillation of bupivacaine with dexmedetomidine (received 40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml).', 'armGroupLabels': ['bupivacaine with dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Zaher', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Zaher Zaki Zaher', 'investigatorAffiliation': 'Aswan University Hospital'}}}}