Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-12 @ 6:07 PM
Study NCT ID:
NCT00616850
Status:
WITHDRAWN
Last Update Posted:
2014-05-22
First Post:
2008-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Orthopedic surgeon that does our knee surgeries moved to a different location', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-20', 'studyFirstSubmitDate': '2008-02-04', 'studyFirstSubmitQcDate': '2008-02-04', 'lastUpdatePostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total PCA opioid consumption', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'Time to first flatus', 'timeFrame': '72 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Intravenous Lidocaine Infusion', 'Femoral Block Catheter'], 'conditions': ['Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Total knee replacement is often associated with severe postoperative pain, especially in the first 24 hours. Patient controlled analgesia (PCA) and continuous femoral block with PCA are commonly used to treat postoperative pain after total knee arthroplasty. However, PCAs use opioids. Opioids are excellent painkillers but their use is hampered by side effects such as nausea, vomiting, bowel dysfunction, urinary retention, pruritus, sedation and respiratory depression. We propose to test the hypothesis that adding a low dose lidocaine infusion to PCAs will lower the amount of opioids that these patients receive, thereby improving patient safety while still providing adequate analgesia. In addition, continuous femoral block has been shown to provide superior postoperative pain control when compared to morphine PCA. Therefore, postoperative pain levels of study subjects will be compared to those subjects who receive a combination of a continuous femoral block catheter with a PCA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Undergoing a total knee arthroplasty\n2. Be American Society of Anesthesiologist physical status 1,2, or 3\n3. Be willing and capable of providing informed consent\n4. Be English speaking\n\nExclusion Criteria:\n\n1. Age greater than 80 years old or younger than 18 years old\n2. Congestive hear failure\n3. Hepatic insufficiency\n4. Neurological disorders\n5. Psychiatric disorders\n6. Steroid treatment\n7. History of atrial fibrillation\n8. Chronic pain disorder with opioid treatment'}, 'identificationModule': {'nctId': 'NCT00616850', 'briefTitle': 'Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Treatment of Postoperative Pain After Total Knee Arthroplasty Using Intravenous Lidocaine Infusion in Combination With Patient Controlled Analgesia Versus Continuous Femoral Block Catheter in Combination With Patient Controlled Analgesia: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study.', 'orgStudyIdInfo': {'id': '57175'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Group A subjects will receive a continuous femoral block catheter and a Patient Controlled Analgesia (PCA).', 'interventionNames': ['Procedure: Continuous femoral catheter block']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Group B subjects will receive a low dose lidocaine (1.33 mg/kg/hr) infusion and a Patient Controlled Analgesia.', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C', 'description': 'Group C subjects will receive placebo (preservative free normal saline) infusion and a Patient Controlled Analgesia.', 'interventionNames': ['Other: Preservative free normal saline']}], 'interventions': [{'name': 'Continuous femoral catheter block', 'type': 'PROCEDURE', 'description': 'A constant infusion of ropivacaine 0.2% without epinephrine will be given to each subject via continuous femoral catheter in Group A.', 'armGroupLabels': ['Group A']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Lidocaine 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.', 'armGroupLabels': ['Group B']}, {'name': 'Preservative free normal saline', 'type': 'OTHER', 'description': 'Preservative free normal saline 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Michelle Schlunt, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}