[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514986":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":25,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Loyola University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IPACK","EXPERIMENTAL","After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of 0.5% bupivacaine will be injected.",[13],"Drug: IPACK",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of normal saline will be injected.",[19],"Drug: PLACEBO",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Infiltration between the popliteal artery and capsules of the knee (IPACK) is a novel ultrasound-guided technique that provides additional regional analgesic relief to the posterior aspect of the knee without complications seen in a sciatic nerve block. The intention of the IPACK block is to anesthetize the terminal sensory nerves while sparing the main trucks of the common peroneal and tibial nerves.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"PLACEBO","The control group will receive the normal pre-procedure care including a pre-operative visit, surgery, and post-operative care. The control group will receive a sham block consisting of saline in the same anatomical location and manner that the intervention IPACK block is administered.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"John Miller, MD","CONTACT","708-216-8730","johnmiller@lumc.edu",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Loyola University Medical Center","RECRUITING","Maywood","Illinois","60153","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-87.84312,41.8792,{"lat":49,"lon":48},[52,56,58],{"name":53,"role":33,"phone":54,"phoneExt":25,"email":55},"Susan Fargo, BA, CIP, CCRP","708-216-8046","sfargo@luc.edu",{"name":32,"role":57,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":59,"role":60,"phone":25,"phoneExt":25,"email":25},"Scott Byram, MD","SUB_INVESTIGATOR",{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100514986","phase-4-ipack-on-early-pain-scores-after-acl-reconstruction-100514986",false,"NCT05985629","IPACK on Early Pain Scores After ACL Reconstruction","The Effect of IPACK Nerve Blocks on Early ACL Pain Scores","Inclusion Criteria:\n\n* All patients presenting to Dr. John Miller with the Department of Orthopedic Surgery, Sports Medicine Division, at Loyola University Medical Center electing to undergo ACL reconstruction surgery.\n* Patients 16 and over\n* English speaking patients\n* Patients who have the capacity to make their own medical decisions and consent to the study\n\nExclusion Criteria:\n\n* Previous surgery on the operative knee\n* Previous knee infection\n* Chronic opioid use\n* Have a known allergy to local anesthetics\n* Patient using autograft (cadaver) for ACL reconstruction.","ALL","16 Years",{"count":73,"type":74},78,"ESTIMATED","INTERVENTIONAL",[77],"PHASE4","The goal of this clinical trial is to learn whether using an anesthetic technique called IPACK block will control pain after ACL reconstruction surgery. The main questions it aims to answer are:\n\n* if participants who receive the IPACK block prior to ACL reconstruction experience less pain after surgery and at 1 day after surgery\n* if participants who receive the IPACK block prior to ACL reconstruction require less short-term opioid use immediately after surgery and up to one week after surgery.\n\nParticipants will be randomized 1:1 to 1 of 2 groups: Use of IPACK block during ACL reconstruction vs. placebo (a placebo is a look-alike substance that contains no active drug). Neither the participant nor the investigator will know which group the participants has been assigned to.\n\nResearchers will compare self-reported pain scores and short-term opioid use of all study participants.",[80,81,82],"Pain, Postoperative","Anterior Cruciate Ligament Injuries","Analgesics, Opioid","2023-08-03",{"date":85,"type":86},"2023-08-14","ACTUAL",{"date":83,"type":86},{"date":89,"type":74},"2026-08-03",{"name":5,"class":6},1]