Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-04 @ 8:45 PM
Study NCT ID:
NCT02812602
Status:
UNKNOWN
Last Update Posted:
2016-06-24
First Post:
2016-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Anesthesia for Removal of Stitches After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-21', 'studyFirstSubmitDate': '2016-04-17', 'studyFirstSubmitQcDate': '2016-06-21', 'lastUpdatePostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale for pain', 'timeFrame': '30min', 'description': 'The person who removes the staples evaluated the pain intensity. The pain intensity is evaluated with visual analog scale for pain'}], 'secondaryOutcomes': [{'measure': 'Complication rate of lidocaine patch', 'timeFrame': 'Two weeks', 'description': 'The incidence of related complications after application of lidocaine patch'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Total Knee Replacement', 'Stitch', 'Removal', 'Pain'], 'conditions': ['Metal Staple Removal After Total Knee Replacement']}, 'descriptionModule': {'briefSummary': 'Lidocaine patch is a safe and effective topical anesthetic agent for removal of metal staples after total knee replacement', 'detailedDescription': 'This is a double-blind randomised control trial. After informed consent, the patients who undergoes primary total knee replacement will be assigned to either control group or experimental group randomly. The effectiveness and complication will be analysed.\n\nIf the patients are not medically fit for the study (including contraindications for lidocaine), they will be excluded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Males and females, aged 50-100 years\n2. The patients who undergo primary total knee replacement (performed by the same surgeon, Dr.Jiang)\n3. Clear consciousness\n4. No contraindication for staple removal on the post-operative day 7\n\nExclusion criteria:\n\n1. Allergy to lidocaine\n2. Patient with second or third degree atrio-ventricular block\n3. Patients with severe Sinoatrial node block\n4. Patients taking class I antiarrhythmia drugs\n5. Pregnant patients\n6. Patients undergoing revision total knee replacement\n7. Contraindication for removal of staples on post-operative day 7'}, 'identificationModule': {'nctId': 'NCT02812602', 'briefTitle': 'Topical Anesthesia for Removal of Stitches After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Topical Anesthesia With Lidocaine Patch for Removal of Metal Staples After Total Knee Arthroplasty: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '201505116MINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine patch', 'description': 'The patients was randomly assigned to experimental group or placebo group. In this arm, lidocaine patches will be applied to the skin surrounding the surgical wound by one nurse practitioner. After more than 20 minutes the patch will be removed. Another nurse practitioner (double blinded) will remove the metal staples and record pain scale.', 'interventionNames': ['Drug: Lidocaine patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The patients was randomly assigned to experimental group or placebo group. In this arm, a placebo patch will be applied to the skin surrounding the surgical wound by one nurse practitioner. After more than 20 minutes the patch will be removed. Another nurse practitioner (double blinded) will remove the metal staples and record pain scale.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Lidocaine patch', 'type': 'DRUG', 'description': 'Lidocain patch will be applied around the surgical wound about 20 minutes before removal of staples.', 'armGroupLabels': ['Lidocaine patch']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo patch will be applied around the surgical wound about 20 minutes before removal of staples.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'test3', 'city': 'Taipei', 'state': 'Test2', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ching-Chuan Jiang', 'role': 'CONTACT', 'email': 'ccj@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '65273'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Tzu-Hao Tseng', 'role': 'CONTACT', 'email': 'b92401004@gmail.com', 'phone': '886-978326537'}, {'name': 'Ching-Chuan Jiang', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Ching-Chuan Jiang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Orthopedic Surgery, National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}