Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-05 @ 4:55 PM
Study NCT ID:
NCT03921034
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2019-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IPACK Nerve Block for Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-17', 'size': 176838, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-04-10T07:02', 'hasProtocol': False}, {'date': '2016-11-17', 'size': 502234, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-15T12:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Only the regional anesthesiologist performing the block will know the randomization status. The study participants, outcome assessors/researchers, other anesthesia personnel, surgeons, physician assistants, and nurses will be blinded to the treatment arm.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-15', 'studyFirstSubmitDate': '2019-04-10', 'studyFirstSubmitQcDate': '2019-04-15', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative opioid consumption (morphine equivalents) in the first 24 hours', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey', 'timeFrame': 'through study completion approximately 2 days'}, {'measure': 'Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm', 'timeFrame': 'through study completion approximately 2 days'}, {'measure': 'Worst pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm', 'timeFrame': 'through study completion approximately 2 days'}, {'measure': 'Walk distance on POD#1 am, POD#1 pm, POD#2', 'timeFrame': 'through study completion approximately 2 days'}, {'measure': 'Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room', 'timeFrame': 'through study completion approximately 2 days'}, {'measure': 'Time to oral-only opioids', 'timeFrame': 'through study completion approximately 2 days'}, {'measure': 'Pain location', 'timeFrame': 'through study completion approximately 2 days'}, {'measure': 'Hospital length of stay', 'timeFrame': 'through study completion approximately 2 days'}, {'measure': 'Incidence of foot drop', 'timeFrame': 'through study completion approximately 2 days'}, {'measure': 'Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm', 'timeFrame': 'through study completion approximately 2 days'}, {'measure': 'Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score', 'timeFrame': 'through study completion approximately 2 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthropathy of Knee', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'Double-blind, randomized controlled clinical trial to test the efficacy of IPACK on postoperative opioid consumption, patient satisfaction, pain scores, mobility, and several other secondary outcomes in adults undergoing primary unilateral TKA.\n\nEnrolled patients will be randomized to either continuous ACB with IPACK or to continuous ACB with sham subcutaneous saline injection. Outcomes assessors and patients will be blinded to the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral, primary tricompartment total knee arthroplasty\n* Age 18 years or older\n* ASA I-III\n* Eligible for spinal or combined spinal epidural anesthetic\n* Able to speak, read, and understand English\n* Willing to participate in the trial\n\nExclusion Criteria:\n\n* Contraindication to regional anesthesia or peripheral nerve blocks\n* Allergy to local anesthetics\n* Allergy to NSAIDs\n* Chronic renal insufficiency with Cr \\> 1.4 or GFR \\< 60\n* Have chronic pain that is not related to their knee joint\n* Have been using opioids on a chronic basis (daily or almost daily opioid use for 3 months or longer)\n* Have a pre-existing peripheral neuropathy involving the operative site\n* Body mass index greater than or equal to 40'}, 'identificationModule': {'nctId': 'NCT03921034', 'briefTitle': 'IPACK Nerve Block for Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Ochsner Health System'}, 'officialTitle': 'Pain After Total Knee Arthroplasty: a Comparison of Combined Continuous Adductor Canal Block With Infiltration of Local Anesthetic Between the Popliteal Artery and Capsule of the Knee Block Versus Continuous Adductor Canal Block Alone on Postoperative Analgesia', 'orgStudyIdInfo': {'id': '2016.307.C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'continuous ACB with IPACK block', 'description': 'ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and IPACK block with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'SHAM_COMPARATOR', 'label': 'continuous ACB with sham subcutaneous saline injection', 'description': 'ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and a sham IPACK block with subcutaneous saline injection along the medial thigh', 'interventionNames': ['Drug: Ropivacaine', 'Drug: Saline']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['Naropin'], 'description': 'All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.', 'armGroupLabels': ['continuous ACB with IPACK block', 'continuous ACB with sham subcutaneous saline injection']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.', 'armGroupLabels': ['continuous ACB with sham subcutaneous saline injection']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Matthew Patterson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ochsner'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ochsner Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Matthew Patterson', 'investigatorAffiliation': 'Ochsner Health System'}}}}