Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT06281418
Status:
COMPLETED
Last Update Posted:
2025-01-10
First Post:
2024-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postoperative Intraperitoneal Pain Management Following Laparoscopic 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': 'D017829', 'term': 'Granisetron'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2024-02-18', 'studyFirstSubmitQcDate': '2024-02-25', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'VAS score', 'timeFrame': '2 hours, 4 hours, 8 hours, 12 hours, 24 hours', 'description': 'Pain intensity: VAS score'}], 'secondaryOutcomes': [{'measure': 'Time to analgesic request', 'timeFrame': '24 hours', 'description': 'Time to first rescue analgesic request'}, {'measure': 'Quality of life (QoL) after laparoscopic cholecystectomy (LC)', 'timeFrame': '3 months', 'description': 'Gastrointestinal Quality of Life Index questionnaire for QOL assessment with calculation of the score; most desirable option: 4 points, least desirable option: 0 points and GIQLI score: sum of the point. GIQLI ranges from 0 to 80 with higher scores indicating a better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic', 'post-operative pain', 'serotonin 5HT3 receptor antagonist'], 'conditions': ['Post Operative Pain']}, 'referencesModule': {'references': [{'pmid': '40698525', 'type': 'DERIVED', 'citation': 'Bayoumi HM, Abdelaziz DH, Boraii S, Bendas ER, El Said NO. Intraperitoneal Granisetron for Post-Laparoscopic Cholecystectomy Pain Management: A Double-Blinded, Randomized Controlled Trial. Pharmacotherapy. 2025 Sep;45(9):547-556. doi: 10.1002/phar.70046. Epub 2025 Jul 23.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated IP granisetron as an adjuvant to standard care for postoperative pain management in patients undergoing LC.', 'detailedDescription': 'Postoperative pain is a main challenge for delayed hospital discharge in Laparoscopic cholecystectomy. . Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. Granisetron is frequently used as a premedication to avoid postoperative nausea and vomiting in patients who have undergone general anesthesia. The purpose of this study is evaluating the efficacy and tolerability of IP granisetron on postoperative pain control in patients undergoing LC'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are scheduled to undergo elective LC.\n* Adults (males and/or females) between the ages of 18-70 years old.\n\nExclusion Criteria:\n\n* Chronic pain other than cholelithiasis.\n* Patients who received analgesics or sedatives 24 h before scheduled surgery.\n* Severe hepatic (Child Pugh Class B and C) and renal dysfunction (CrCl \\<30ml/min)\n* Previous allergic response to granisetron.\n* Pregnancy and lactation\n* Patients with communication problems, cognitive dysfunction, or psychological disorders\n* Daily corticosteroid use'}, 'identificationModule': {'nctId': 'NCT06281418', 'briefTitle': 'Postoperative Intraperitoneal Pain Management Following Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Future University in Egypt'}, 'officialTitle': 'Postoperative Pain Management Following Laparoscopic Cholecystectomy- Intraperitoneal Granisetron', 'orgStudyIdInfo': {'id': '5-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': '2 ml IP normal saline (0.9 % NaCl)', 'interventionNames': ['Other: Normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': '2ml IP granisetron (1 mg/mL)', 'interventionNames': ['Drug: Granisetron 1 Mg/mL Intravenous Solution']}], 'interventions': [{'name': 'Granisetron 1 Mg/mL Intravenous Solution', 'type': 'DRUG', 'description': '2mL intraperitoneal adminstration of granisetron (1 mg/mL)', 'armGroupLabels': ['Intervention arm']}, {'name': 'Normal saline', 'type': 'OTHER', 'description': '2 ml IP normal saline (0.9% NaCl)', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11617', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Hepatology and Tropical Research Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Future University in Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant- Pharmacy Practice & Clinical Pharmacy', 'investigatorFullName': 'Hoda Mohamed', 'investigatorAffiliation': 'Future University in Egypt'}}}}