Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT00413127
Status:
TERMINATED
Last Update Posted:
2015-06-26
First Post:
2006-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perioperative Protective Effects of Lidocaine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'whyStopped': 'Less patients than expected for inclusion, therefore patient recruitment is to low', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-25', 'studyFirstSubmitDate': '2006-12-18', 'studyFirstSubmitQcDate': '2006-12-18', 'lastUpdatePostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'length of postoperative hospital stay', 'timeFrame': 'end of hospital stay'}], 'secondaryOutcomes': [{'measure': 'Hyperalgesia perioperative', 'timeFrame': 'postoperative day 2, 4, 8, end of hospital stay and follow-up'}, {'measure': 'Cytokine levels perioperative', 'timeFrame': 'before surgery and 4 hours, 2 and 4 days after surgery'}, {'measure': 'Bowel motility perioperative', 'timeFrame': 'days after surgery'}, {'measure': 'Length of PACU stay', 'timeFrame': 'end of PACU stay'}, {'measure': 'Cognitive function perioperatively', 'timeFrame': 'before surgery, one and four days after surgery, at end of hospital stay and follow-up'}, {'measure': 'Incidence of wound healing disturbances', 'timeFrame': 'within 4 weeks after surgery'}, {'measure': 'Postoperative Analgesia', 'timeFrame': 'until end of hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Systemic lidocaine', 'peridural lidocaine', 'perioperative analgesia', 'inflammation', 'Anesthesia'], 'conditions': ['Elective Surgical Procedure', 'Colorectal Surgery']}, 'referencesModule': {'references': [{'pmid': '16952918', 'type': 'BACKGROUND', 'citation': 'Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. doi: 10.1093/bja/ael217. Epub 2006 Sep 4.'}, {'pmid': '71604', 'type': 'BACKGROUND', 'citation': 'Cooke ED, Bowcock SA, Lloyd MJ, Pilcher MF. Intravenous lignocaine in prevention of deep venous thrombosis after elective hip surgery. Lancet. 1977 Oct 15;2(8042):797-9. doi: 10.1016/s0140-6736(77)90727-9.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to comparing effects of intravenously (IV) administered lidocaine to effects of epidurally (ED) administered lidocaine in patients undergoing elective colorectal surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective colorectal surgery\n\nExclusion Criteria:\n\n* ASA \\> 3\n* history of anti-inflammatory therapy\n* history of inflammatory bowl diseases\n* history of chronic pain treatment'}, 'identificationModule': {'nctId': 'NCT00413127', 'briefTitle': 'Perioperative Protective Effects of Lidocaine', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Perioperative Protective Effects of Lidocaine - Clinical Study on the Route and Timing of Administration', 'orgStudyIdInfo': {'id': '06-AnIt-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Lidocaine i.v', 'interventionNames': ['Drug: lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'intraoperatively lidocaine epidural postoperatively lidocaine i.v.', 'interventionNames': ['Drug: lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'intraoperatively lidocaine i.v. postoperatively lidocaine epidural', 'interventionNames': ['Drug: lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'lidocaine epidural', 'interventionNames': ['Drug: lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '5', 'description': 'placebo i.v.', 'interventionNames': ['Drug: NaCl 0,9%']}], 'interventions': [{'name': 'lidocaine', 'type': 'DRUG', 'description': 'administration of lidocaine intravenously or epidural or administration of placebo', 'armGroupLabels': ['1', '2', '3', '4']}, {'name': 'NaCl 0,9%', 'type': 'DRUG', 'description': 'Administration of placebo i.v.', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-48129', 'city': 'Münster', 'country': 'Germany', 'facility': 'University Hospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': 'D-48145', 'city': 'Münster', 'country': 'Germany', 'facility': 'St. Franziskushospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': 'D-49377', 'city': 'Vechta', 'country': 'Germany', 'facility': 'St. Marienhospital', 'geoPoint': {'lat': 52.72632, 'lon': 8.28598}}], 'overallOfficials': [{'name': 'K Hahnenkamp, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anesthesiology and Intensive Care, University Hospital Muenster'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'collaborators': [{'name': 'International Anesthesia Research Society (IARS)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}