Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
Study NCT ID:
NCT06685250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-11-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postoperative Pain After a 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': 'D017081', 'term': 'Cholecystectomy, Laparoscopic'}], 'ancestors': [{'id': 'D002763', 'term': 'Cholecystectomy'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-11', 'studyFirstSubmitDate': '2024-11-08', 'studyFirstSubmitQcDate': '2024-11-11', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'Hour 6', 'description': 'Visual Analog Scale (VAS) .from 0 to 10 0 no pain, 5 moderate pain, 10 worst possible pain'}], 'secondaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': 'Hour 12', 'description': 'Visual Analog Scale (VAS) 0 no pain, 10 worst possible pain'}, {'measure': 'Postoperative pain', 'timeFrame': 'Hour 24', 'description': 'Visual Analog Scale 0 no pain, 10 worst possible pain'}, {'measure': 'vommiting (PONV score)', 'timeFrame': 'from 0 to 24 hours after surgery', 'description': 'Postoperative Nausea and vomiting (PONV) score 0 no PONV , 1 moderate nausea, 2 moderate vomiting, 3 uncontrollable nausea and/or vomiting'}, {'measure': 'morbidity', 'timeFrame': '30 days'}, {'measure': 'postoperative length of stay', 'timeFrame': '30 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '41411326', 'type': 'DERIVED', 'citation': 'Ben Safta A, Nasri S, Samaali I, Taher H, Trabelsi MM, Dziri C, Dougaz W, Nouira R. Randomized controlled trial comparing low pressure (8 mmHg) versus high pressure (14 mmHg) CO2 insufflation on postoperative pain in patients undergoing laparoscopic cholecystectomy: Protocol. PLoS One. 2025 Dec 18;20(12):e0339161. doi: 10.1371/journal.pone.0339161. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'Randomized Controlled Trial to compare the effect of low (8 mmHg) versus Standard (14 mmHg) insufflation pressure of CO2 pneumoperitoneum on postoperative pain in patients undergoing laparoscopic cholecystectomy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1 or ASA 2\n* uncomplicated symptomatic gallblader lithiasis scheduled for elective surgery\n* no choledocholithiasis\n* no associated surgical procedures\n* no cerebrovasculare accident with neurological sequelae or other neurological disorders that affects sensation of pain\n* no ascites\n* no carcinomatosis\n\nExclusion Criteria:\n\n* conversion to laparotomy\n* need to keep an escat drain'}, 'identificationModule': {'nctId': 'NCT06685250', 'acronym': 'CPOP', 'briefTitle': 'Postoperative Pain After a Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Charles Nicolle'}, 'officialTitle': 'Randomized Controlled Trial Comparing Low (8 MmHg) Vs. Standard (14 MmHg) CO2 Insufflation Pressure on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'Chir-BS-2024-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pressure 8 mmHg', 'interventionNames': ['Procedure: Laparoscopic cholecystectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pressure 14 mmHg', 'interventionNames': ['Procedure: Laparoscopic cholecystectomy']}], 'interventions': [{'name': 'Laparoscopic cholecystectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic cholecystectomy', 'armGroupLabels': ['Pressure 14 mmHg', 'Pressure 8 mmHg']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Amine Ben Safta, Assistant hospitalo-universita', 'role': 'CONTACT', 'email': 'amine.bsa@gmail.com', 'phone': '+216 29 693 979'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Charles Nicolle', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'surgical fellow in General Surgery', 'investigatorFullName': 'Dr Amine BEN SAFTA', 'investigatorAffiliation': 'Hopital Charles Nicolle'}}}}