Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-30 @ 5:37 AM
Study NCT ID:
NCT01199406
Status:
COMPLETED
Last Update Posted:
2010-09-13
First Post:
2010-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Reduction After Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D042882', 'term': 'Gallstones'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-10', 'studyFirstSubmitDate': '2010-09-09', 'studyFirstSubmitQcDate': '2010-09-10', 'lastUpdatePostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal Pain in Visual Analogue Scale (VAS 0-100mm)', 'timeFrame': '24 h postoperatively', 'description': 'Postoperative abdominal pain'}], 'secondaryOutcomes': [{'measure': 'Shoulder pain', 'timeFrame': '24 h', 'description': 'Postoperative shoulder pain'}, {'measure': 'Rescue Analgesics', 'timeFrame': '24 h postoperatively', 'description': 'The need of rescue analgesics within the 24h postoperatively'}, {'measure': 'adverse events caused by the investigational procedure or by levobupivacaine itself', 'timeFrame': 'Intra- and postoperative up to 24 hours', 'description': 'Adverse events were defined as neurological or cardial effects attributable to use of levobupivacaine. Adverse events by the procedure such as bleeding were also registered.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Maximum two weeks'}, {'measure': 'intra-operative complications including perforation of the gallbladder, bile duct injury, bowel injury and injury to vascular structures', 'timeFrame': 'intraoperative, 1 hour'}, {'measure': 'postoperative complications during hospitalisation', 'timeFrame': 'during hospitalisation (up to two weeks)', 'description': 'Infection, bleeding, embolisation etc.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gallstone', 'gallbladder', 'cholecystectomy', 'laparoscopic', 'pain'], 'conditions': ['Cholecystolithiasis', 'Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '21412996', 'type': 'DERIVED', 'citation': 'Hilvering B, Draaisma WA, van der Bilt JD, Valk RM, Kofman KE, Consten EC. Randomized clinical trial of combined preincisional infiltration and intraperitoneal instillation of levobupivacaine for postoperative pain after laparoscopic cholecystectomy. Br J Surg. 2011 Jun;98(6):784-9. doi: 10.1002/bjs.7435. Epub 2011 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'To determine the effect of combined intracutaneous infiltration and intraperitoneal instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic cholecystectomy on abdominal pain up to 24 hours after surgery.', 'detailedDescription': 'The primary endpoint of this study was postoperative abdominal pain as measured by a visual analogue scale (VAS), using a VAS lineal with a slide. The patient was asked to indicate a score from 0 to 100 corresponding to his or her pain. At 0.5, 2, 4, 8 and 24 hours after the surgical procedure the primary investigator visited the patient to obtain the VAS scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 18 and 80\n* ASA I or II\n* with symptomatic gallstone disease which requires elective laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* acute cholecystitis, cholangitis, severe acute pancreatitis, advanced liver cirrhosis or suspected gallbladder cancer,\n* a medical history of epilepsy, cardiac arrhythmias or chronic pain of any kind, - allergy to amid type drugs\n* pregnancy\n* patients suffering from hypotension or hypovolemia\n* infectious liver disease\n* conditions obstructing adequate pain scoring\n* patients using drugs that deduce function of the CYP3A4 or CYP1A2 system\n* patients having an American Society of Anaesthesiologists (ASA) classification of three or higher.'}, 'identificationModule': {'nctId': 'NCT01199406', 'acronym': 'INTENSE', 'briefTitle': 'Pain Reduction After Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Meander Medical Center'}, 'officialTitle': 'Combined Preincisional Infiltration and Intraperitoneal Instillation of Levobupivacaine for Postoperative Pain Reduction After Laparoscopic Cholecystectomy; A Double-blind Placebo-controlled Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'Intense Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline', 'description': '80 mL 0.9% NaCl', 'interventionNames': ['Drug: Levobupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Levobupivacaine', 'description': '80mL 0.125% levobupivacaine', 'interventionNames': ['Drug: Levobupivacaine']}], 'interventions': [{'name': 'Levobupivacaine', 'type': 'DRUG', 'otherNames': ['Chirocaine (brand name)', 'NDA 20-997'], 'description': '0.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally', 'armGroupLabels': ['Levobupivacaine', 'normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3811ES', 'city': 'Amersfoort', 'state': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Meander MC', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}], 'overallOfficials': [{'name': 'Werner A Draaisma, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Meander MC'}, {'name': 'Bart Hilvering, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meander MC'}, {'name': 'Esther CJ Consten, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Meander MC'}, {'name': 'Kristine E Kofman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Meander MC'}, {'name': 'Rene M Valk, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Meander MC'}, {'name': 'Jarmila DW Van der Bilt, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Meander MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meander Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'dr. Consten', 'oldOrganization': 'Meander medical Center'}}}}