Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-02 @ 11:18 AM
Study NCT ID:
NCT05316168
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2021-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Operative Pain Management for ACL Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C514822', 'term': 'oxycodone-acetaminophen'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative pain management', 'timeFrame': '14 days', 'description': 'This will be measured by the participants completing a pain and medication Use questionnaire'}, {'measure': 'Post operative pain management 2', 'timeFrame': '6 months', 'description': 'Participants will also complete the International Knee Documentation Committee (IKDC) questionnaires'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Health care providers are seeking methods to limit post-operative pain and opioid prescriptions to reduce the burden of the national opioid use epidemic. Adductor canal block (ACB) is a peripheral nerve block that has been shown to reduce pain and opioid usage with minimal effect on quadriceps function in patients undergoing arthroscopic knee surgery. Infiltration between Popliteal Artery and Capsule of the Knee (iPACK) block has also shown promise in reducing pain and opioid usage, specifically reducing posterior knee pain, which ACB is not able to achieve. To our knowledge, there is currently no study in the orthopedic literature comparing post-operative pain and opioid consumption in ACL reconstruction (ACLR) patients who received isolated ACB versus ACB with IPACK.\n\nThe primary aim of this study is to investigate the role of IPACK in combination with ACB in reducing peri-operative (14-days) pain levels in ACLR patients. The secondary aim is to determine the effectiveness of IPACK in reducing post-operative opioid use. The tertiary aim is to determine any effect of IPACK on post-operative functional outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients undergoing primary ACLR for ACL tear, including patients with concomitant meniscectomy or meniscal repair.\n\nExclusion Criteria:\n\n* Revision ACLR, worker's compensation, pregnancy, age\\<18 years"}, 'identificationModule': {'nctId': 'NCT05316168', 'briefTitle': 'Post Operative Pain Management for ACL Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'Isolated Adductor Canal Block vs Adductor Canal Block With IPACK in ACL Reconstruction: A Randomized, Prospective Trial', 'orgStudyIdInfo': {'id': 'ftjo21D.1099'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'isolated adductor canal block (ACB)', 'description': 'Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone.', 'interventionNames': ['Drug: Bupivacaine HCl 0.5% Injectable Solution', 'Drug: Dexamethasone', 'Drug: Percocet 5Mg-325Mg Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'isolated adductor canal block (ACB) + IPACK', 'description': 'ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone.', 'interventionNames': ['Drug: Bupivacaine HCl 0.5% Injectable Solution', 'Drug: Dexamethasone', 'Procedure: Infiltration between Popliteal Artery and Capsule of the knee (iPACK)', 'Drug: Percocet 5Mg-325Mg Tablet']}], 'interventions': [{'name': 'Bupivacaine HCl 0.5% Injectable Solution', 'type': 'DRUG', 'description': 'During adductor canal block participants will receive 20cc of Bupivacaine HCl 0.5%', 'armGroupLabels': ['isolated adductor canal block (ACB)', 'isolated adductor canal block (ACB) + IPACK']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'During adductor canal block participants will receive 2mg Dexamethasone', 'armGroupLabels': ['isolated adductor canal block (ACB)', 'isolated adductor canal block (ACB) + IPACK']}, {'name': 'Infiltration between Popliteal Artery and Capsule of the knee (iPACK)', 'type': 'PROCEDURE', 'description': 'Prior to closing the surgical wound participants will receive a local injections of 20cc 0.5% bupivacaine mixed with 2mg dexamethasone', 'armGroupLabels': ['isolated adductor canal block (ACB) + IPACK']}, {'name': 'Percocet 5Mg-325Mg Tablet', 'type': 'DRUG', 'description': 'Participant will receive 20 Percocet 5/325mg tablets post surgery for pain control', 'armGroupLabels': ['isolated adductor canal block (ACB)', 'isolated adductor canal block (ACB) + IPACK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}