[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pacira Pharmaceuticals, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,38,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100477312","innovations-in-genicular-outcomes-registry-100477312",false,"NCT05495334","Innovations in Genicular Outcomes Registry","iGOR","Inclusion Criteria:\n\n1. Planned to receive treatment for knee OA pain including, but not limited to, knee injections, nerve blocking procedures, or knee arthroplasty within 60 days of screening\n2. Able to understand the informed consent and assessment questionnaires and have the ability to complete them in the opinion of the investigator\n3. Have access to a smartphone or internet access with a computer\u002Ftablet to complete the questionnaires using the registry application\n\nExclusion Criteria:\n\n1. Actively enrolled in an investigational trial that would preclude patients from receiving the site's standard of care for knee OA pain or knee arthroplasty recovery protocol\n2. Planning to have a surgery other than on the target knee","ALL",{"count":18,"type":19},10000,"ESTIMATED","18 Months","OBSERVATIONAL","The registry will capture prospective data on patients receiving pain management for chronic pain due to knee osteoarthritis (OA) or pain optimization for knee arthroplasty due to knee OA. The OA pain therapies may include cryo nerve block, radiofrequency ablation (RFA), intra-articular (IA) corticosteroids, viscosupplementation, opioids, and others (e.g., non-steroidal anti-inflammatory drugs \\[NSAIDs\\]).",[24],"Knee Osteoarthritis","RECRUITING","2026-06-08",{"date":28,"type":29},"2026-06-09","ACTUAL",{"date":31,"type":29},"2021-09-23",{"date":33,"type":19},"2033-12-30",{"name":35,"class":36},"Pacira Pharmaceuticals, Inc","INDUSTRY",19,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":45,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100542252","study-to-assess-the-efficacy-and-safety-of-iovera-system-in-subjects-with-upper-extremity-spasticity-100542252","NCT06340451","Study to Assess the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity","A Multicenter, Randomized, Double-Blind, Sham-Controlled Study Assessing the Efficacy and Safety of Iovera®° System in Subjects With Upper Extremity Spasticity","Inclusion Criteria:\n\n1. Male or female, 18 years and above.\n2. A confirmed diagnosis of any cerebral or spinal condition, at least 6 months before Screening, resulting in spasticity of the muscles controlling the shoulder and elbow.\n3. Not on oral medications for spasticity management or if on any oral medications, the oral medication taken chronically for spasticity management (eg, oral baclofen) must be maintained at a stable dose for at least 4 weeks before screening for the study.\n4. Not on an intrathecal baclofen pump or if on an intrathecal baclofen pump for spasticity management, must be maintained at a stable dose for six months or more before screening for the study.\n5. Must have a score on the Modified Ashworth Scale of 2 or more in the targeted area (shoulder and elbow) at Screening and at Baseline (Day-1 pretreatment).\n6. A diagnostic nerve block using lidocaine (1% lidocaine, 2 to 3 mL per target nerve) showing a positive response (at least one point reduction from the screening Modified Ashworth Scale score for elbow extension and shoulder abduction) to the targeted nerves, should be performed within 30 days to at least 6 hours before study treatment. The diagnostic nerve block effect must be completely resolved before pretreatment evaluation and the study treatment.\n7. Subject, in the investigator's opinion, will not be exposed to unacceptable risk by participation.\n8. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.\n\nExclusion Criteria:\n\n1. History of stroke, traumatic brain injury, and\u002For spinal cord injury in less than 6 months.\n2. Diagnosis of cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, or Raynaud's disease.\n3. History of neurotoxin injections within the past 3 months.\n4. Previous injection with phenol or ethyl alcohol at any time in the target areas (shoulder or elbow).\n5. Previous surgical intervention that altered the target neuroanatomy of the upper limb.\n6. Current or planned enrollment in an investigational drug or device study for the management of spasticity for the duration of the study.\n7. Medical instability that interferes with tolerability to spasticity treatment with the study device as per the investigator's discretion.\n8. Any hospitalization within 4 weeks before Screening\n9. Diagnosis of amyotrophic lateral sclerosis or any lower motor neuron conditions\n10. Allergy or intolerance to amide local anesthetics.\n11. Any skin condition in or around the target area that, in the opinion of the investigator, could adversely impact treatment.\n12. Currently pregnant, nursing, or planning to become pregnant during the study.\n13. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.\n14. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.\n15. Subject, in the opinion of the investigator, is not a suitable candidate for study participation (eg, history of multiple missed office visits, any related upper limb injury).\n16. Subject is unable to adhere to the assessment schedule.","18 Years",{"count":47,"type":19},132,"INTERVENTIONAL",[50],"NA","This multicenter, randomized, double-blind, sham-controlled study is designed to evaluate the efficacy and safety of the iovera° system in subjects with upper extremity spasticity. A total of approximately 132 subjects will be enrolled; 88 subjects will receive treatment with the iovera° system and 44 subjects will receive sham treatment (sham iovera° system treatment).",[53],"Spasticity, Cerebral or Spinal Condition",[55,56,57],"spasticity","cerebral","Spinal","2026-04-07",{"date":60,"type":29},"2026-04-09",{"date":62,"type":29},"2024-07-11",{"date":64,"type":19},"2026-08",{"name":35,"class":36},18,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":48,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100536933","phase-1-study-to-evaluate-the-pharmacokinetics-and-safety-of-exparel-for-postoperative-analgesia-in-subjects-undergoing-cardiac-surgery-100536933","NCT06271265","Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Undergoing Cardiac Surgery","A Multicenter, Open-label, Randomized, Bupivacaine-Controlled Study to Evaluate the Pharmacokinetics and Safety of EXPAREL for Postoperative Analgesia in Subjects Aged 0 to Less Than 6 Years Undergoing Cardiac Surgery","Inclusion Criteria:\n\nAll of the following inclusion criteria must be met for eligibility:\n\n1. Pediatric participants with congenital heart defects planned to undergo cardiac surgery with cardiopulmonary bypass\n2. Male or female participants from 0 to less than 6 years of age on the day of surgery: 2 years to less than 6 years of age for Part 1; 6 months to less than 2 years of age for Part 2; 0 to less than 6 months of age for Part 3\n3. American Society of Anesthesiologists (ASA) Classes 1 through 4.\n4. Parent\u002Fguardian is able to speak, read, and understand the language of the ICF and provide informed consent for the participant.\n5. Parent\u002Fguardian is able to adhere to the study visit schedule and complete all study assessments for the participant.\n\nExclusion Criteria:\n\nExclusion Criteria:\n\nA participant will not be eligible for the study if any of the following exclusion criteria are met:\n\n1. History of hypersensitivity or idiosyncratic reactions or contradictions to EXPAREL, bupivacaine HCl, or other amide-type local anesthetics or to opioid medications\n2. Administration of EXPAREL or bupivacaine HCl within 30 days prior to IP administration\n3. Administration of an IP within 30 days or 5 elimination half-lives of such IP, whichever is longer, prior to IP administration, or planned administration of another IP or procedure during participation in this study\n4. History of preterm birth (before 35 weeks of pregnancy)\n5. History of coagulopathies or immunodeficiency disorders\n6. Disease or condition that, in the opinion of the Investigator, indicates an increased vulnerability to IPs and\u002For procedures\n7. Recent or potential exposure to COVID-19\n8. Cardiac surgery has been canceled and cannot be rescheduled within 30 days of signing the ICF because of any reason.\n9. Necessity in delayed wound closure\n10. Informed consent withdrawn before randomization","0 Years","6 Years",{"count":77,"type":19},48,[79],"PHASE1","This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local infiltration analgesia (LIA).",[82],"Postoperative Pain",[84,85,86],"Analgesia","Cardiac Surgery","Pediatric","2025-12-19",{"date":89,"type":29},"2025-12-29",{"date":91,"type":29},"2024-03-29",{"date":93,"type":19},"2027-01",{"name":35,"class":36},5,""]