Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-02-20 @ 1:33 PM
Study NCT ID:
NCT06952556
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-01
First Post:
2025-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following HTO/DFO/TTO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-06-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-04-28', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid Utilization for First 24 Hours Post-Surgery', 'timeFrame': 'Up to Hour 24 Post-Procedure (Post-Operative Day 1 [POD 1])', 'description': 'Opioid utilization for the first 24 hours after surgery, including during surgery, calculated as oral morphine equivalent.'}], 'secondaryOutcomes': [{'measure': 'Length of Stay in PACU', 'timeFrame': 'Post-Operation (POD 0 - typically up to 3 hours)', 'description': 'Length of time the patient is in the PACU prior to discharge.'}, {'measure': 'Patient-Reported Visual Analogue Scale (VAS) Score - Baseline', 'timeFrame': 'Baseline', 'description': 'Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.'}, {'measure': 'Patient-Reported VAS Score in Post-Anesthesia Care Unit (PACU)', 'timeFrame': 'Post-Operation (POD 0 - typically up to 3 hours)', 'description': 'Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.'}, {'measure': 'Patient-Reported VAS Score - Post-Operative Day 1 (POD 1)', 'timeFrame': 'POD 1', 'description': 'Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.'}, {'measure': 'Patient-Reported VAS Score - Post-Operative Day 2 (POD 2)', 'timeFrame': 'POD 2', 'description': 'Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.'}, {'measure': 'Patient-Reported VAS Score - Post-Operative Day 3 (POD 3)', 'timeFrame': 'POD 3', 'description': 'Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.'}, {'measure': 'Patient-Reported VAS Score - Post-Operative Day 7 (POD 7)', 'timeFrame': 'POD 7', 'description': 'Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.'}, {'measure': 'Patient-Reported VAS Score - Month 6 Follow-Up', 'timeFrame': 'Month 6 Post-Operation', 'description': 'Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.'}, {'measure': 'Knee injury and Osteoarthritis Outcome Score (KOOS) - Physical Function Shortform (KOOS-PS) Score - Baseline', 'timeFrame': 'Baseline', 'description': '7-item assessment of how well participants are able to perform different activities. Each item is rated on a 5-point Likert scale (0 to 4), with 0 representing "none" and 4 representing "extreme". The raw score is the sum of responses and is converted to a total score ranging from 0-100, where higher scores indicate greater function.'}, {'measure': 'KOOS-PS Score - Month 6 Follow-Up', 'timeFrame': 'Month 6 Post-Operation', 'description': '7-item assessment of how well participants are able to perform different activities. Each item is rated on a 5-point Likert scale (0 to 4), with 0 representing "none" and 4 representing "extreme". The raw score is the sum of responses and is converted to a total score ranging from 0-100, where higher scores indicate greater function.'}, {'measure': 'Kujala Score / Anterior Knee Pain Scale (AKPS) - Baseline', 'timeFrame': 'Baseline', 'description': '13-item self-report questionnaire that assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome. The total score is the sum of responses and ranges from 0 to 100, with 100 being the highest possible score. Lower scores reflect greater pain and disability.'}, {'measure': 'Kujala Score / AKPS - Month 6 Follow-Up', 'timeFrame': 'Month 6 Post-Operation', 'description': '13-item self-report questionnaire that assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome. The total score is the sum of responses and ranges from 0 to 100, with 100 being the highest possible score. Lower scores reflect greater pain and disability.'}, {'measure': 'Tegner Activity Scale (TAS) Score - Baseline', 'timeFrame': 'Baseline', 'description': "The Tegner Activity Scale (TAS) is a 1-item, self-administered questionnaire used to assess a patient's ability to engage in work and sports activities. The item is rated on a scale of 0 to 10, with 0 representing maximum disability and 10 representing elite sports participation. The total score is the item response."}, {'measure': 'Tegner Activity Scale (TAS) Score - Month 6 Follow-Up', 'timeFrame': 'Month 6 Post-Operation', 'description': "The Tegner Activity Scale (TAS) is a 1-item, self-administered questionnaire used to assess a patient's ability to engage in work and sports activities. The item is rated on a scale of 0 to 10, with 0 representing maximum disability and 10 representing elite sports participation. The total score is the item response."}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': 'A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing high tibial osteotomy (HTO)/distal femoral osteotomy (DFO)/tibial tubercle osteotomy (TTO).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18 and 75 years of age\n* Patients undergoing HTO/DFO/TTO.\n* American Society of Anesthesiologists (ASA) I or II\n\nExclusion Criteria:\n\n* Patients younger than 18 and older than 75.\n* Patients with multi-ligament injury\n* Patients undergoing concomitant cartilage procedure or ACLR.\n* Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer.\n* Patients who are allergic to oxycodone;\n* Patients with diagnosed or self-reported cognitive dysfunction;\n* Patients with a history of neurologic disorder that can interfere with pain sensation;\n* Patients with a history of drug or recorded alcohol abuse;\n* Patients who are unable to understand or follow instructions;\n* Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;\n* Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;\n* Patients with a BMI over 45;\n* Any patient that the investigators feel cannot comply with all study related procedures;\n* Any pregnant patient; assessed via urine pregnancy test in the preoperative area as part of standard preoperative surgical protocol;'}, 'identificationModule': {'nctId': 'NCT06952556', 'briefTitle': 'Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following HTO/DFO/TTO', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Randomized, Single-blind, Single-center Study Measuring the Effects of Adductor Canal Block Combined With IPACK Infiltration Compared to Adductor Canal Block Alone on Post-operative Pain and Opioid Consumption in Patients Undergoing HTO/DFO/TTO', 'orgStudyIdInfo': {'id': '24-01855'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adductor Canal Block (ACB) + IPACK Block', 'description': 'Participants receive ACB with IPACK block.', 'interventionNames': ['Drug: ACB', 'Drug: IPACK block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Isolated Adductor Canal Block', 'description': 'Participants receive ACB only.', 'interventionNames': ['Drug: ACB']}], 'interventions': [{'name': 'ACB', 'type': 'DRUG', 'description': '15 mL of 0.25% Bupivacaine block of the saphenous nerve injected under ultrasound guidance via adductor canal.', 'armGroupLabels': ['Adductor Canal Block (ACB) + IPACK Block', 'Isolated Adductor Canal Block']}, {'name': 'IPACK block', 'type': 'DRUG', 'description': 'IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee', 'armGroupLabels': ['Adductor Canal Block (ACB) + IPACK Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Laith Jazrawi, MD', 'role': 'CONTACT', 'email': 'Laith.jazrawi@nyulangone.org', 'phone': '646-501-7223'}], 'overallOfficials': [{'name': 'Laith Jazrawi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The Investigators will not be sharing this information with other researchers beyond publishing our findings in a scientific journal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}