Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-22 @ 11:39 AM
Study NCT ID:
NCT04603950
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2020-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IPICK Blocking for TKA With Moderate Flexion Contracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2020-10-26', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of pain', 'timeFrame': '6 hours after surgery', 'description': 'Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.'}, {'measure': 'evaluation of pain', 'timeFrame': 'postoperative day 1', 'description': 'Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.'}, {'measure': 'evaluation of pain', 'timeFrame': 'postoperative day 2', 'description': 'Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.'}, {'measure': 'evaluation of pain', 'timeFrame': 'postoperative day 3', 'description': 'Visual Analog Score for pain at rest, straightening, flexion at 45 ° and walking, the minimum and maximum values are 0 to 10, higher scores mean a worse outcome.'}, {'measure': 'extension angle', 'timeFrame': 'before surgery', 'description': 'degree of the extension of knee'}, {'measure': 'extension angle', 'timeFrame': '0 hour after surgery', 'description': 'degree of the extension of knee'}, {'measure': 'extension angle', 'timeFrame': '6 hour after surgery', 'description': 'degree of the extension of knee'}, {'measure': 'extension angle', 'timeFrame': 'postoperative day 1', 'description': 'degree of the extension of knee'}, {'measure': 'extension angle', 'timeFrame': 'postoperative day 2', 'description': 'degree of the extension of knee'}, {'measure': 'extension angle', 'timeFrame': 'postoperative day 3', 'description': 'degree of the extension of knee'}], 'secondaryOutcomes': [{'measure': 'range of motion', 'timeFrame': '6 hour after surgery', 'description': 'degree of range of motion from extension to flexion of knee'}, {'measure': 'range of motion', 'timeFrame': 'postoperative day 1', 'description': 'degree of range of motion from extension to flexion of knee'}, {'measure': 'range of motion', 'timeFrame': 'postoperative day 2', 'description': 'degree of range of motion from extension to flexion of knee'}, {'measure': 'range of motion', 'timeFrame': 'postoperative day 3', 'description': 'degree of range of motion from extension to flexion of knee'}, {'measure': 'opioid consumption', 'timeFrame': 'through hospitalization, an average of 7 days', 'description': 'total opioid consumption measured by milliliter.'}, {'measure': 'nerve block related symptoms', 'timeFrame': 'through hospitalization, an average of 7 days', 'description': 'the incidence of numbness of the nerve related skin'}, {'measure': 'postoperative acute pain', 'timeFrame': 'through hospitalization, an average of 7 days', 'description': 'number of cases whose Visual Analog Score for pain was more than 5'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IPACK', 'knee osteoarthritis', 'Flexion Contracture of Knees'], 'conditions': ['Knee Osteoarthritis', 'Flexion Contracture of Knees', 'Anesthesia, Local']}, 'descriptionModule': {'briefSummary': 'Clinical effect of intermittent multiple IPICK blocking on TKA for knee osteoarthritis with flexion contracture between 5 ° and 10 °', 'detailedDescription': 'From October 2020 to January 2021, 40 knee osteoarthritis patients with flexion contracture between 5 ° and 10 ° total knee arthroplasty are enrolled in this study. 20 patients are treated with Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of the Knee, and 20 patients are treated with Adductor Canal Block alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The diagnosis was knee osteoarthritis\n2. The flexion contracture was between 5 and 10 degrees\n3. ASA grade I-III\n\nExclusion Criteria:\n\n1. Lower extremity neuropathy.\n2. Contraindications of nerve anesthesia or regional anesthesia.\n3. unable to cooperate, allergic to the drugs used in this study.\n4. Non steroidal anti-inflammatory drugs are not tolerated.\n5. chronic opioid consumption (daily or almost daily use)'}, 'identificationModule': {'nctId': 'NCT04603950', 'briefTitle': 'IPICK Blocking for TKA With Moderate Flexion Contracture', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'IPICK Blocking for Extension Recovery in TKA With Preoperative Moderate Flexion Contracture', 'orgStudyIdInfo': {'id': 'QiXin2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'The first 20 patients received Continue Adductor Canal Block + Infiltration between the Popliteal Artery and Capsule of the Knee', 'interventionNames': ['Procedure: CACB+IPACK']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': 'The second 20 patients received Continue Adductor Canal Block alone', 'interventionNames': ['Procedure: CACB']}], 'interventions': [{'name': 'CACB+IPACK', 'type': 'PROCEDURE', 'description': 'continue adductor canal block plus Infiltration between the Popliteal Artery and Capsule of the Knee', 'armGroupLabels': ['study group']}, {'name': 'CACB', 'type': 'PROCEDURE', 'description': 'continue adductor canal block', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changchun', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}