[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552304":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":72,"collaborators":43,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":43,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":43,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":43,"overallStatus":50,"whyStopped":43,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Local infiltration with liposomal bupivacaine","EXPERIMENTAL","Patients randomized into the liposomal bupivacaine group will receive anesthesia and undergo standard posterior spinal fusion surgery. The local infiltration would occur in a single stage, after instrumentation and correction maneuver is performed, just prior to closure of the deep fascial layer. The dose would be injected via multiple small volume injections into the paraspinal musculature, spaced approximately 1 cm apart.",[13],"Drug: Bupivacaine liposome injectable suspension",{"label":15,"type":16,"description":17,"interventionNames":18},"Local infiltration with 0.25% bupivacaine with epinephrine","ACTIVE_COMPARATOR","Patients randomized into the 0.25% bupivacaine with epinephrine group will receive anesthesia and undergo standard posterior spinal fusion surgery under the same condition as the intervention group with one exception: the local infiltration will be made up of equal volume of 0.25% bupivacaine with epinephrine. The equal volume of 0.25% bupivacaine with epinephrine will be used in the exact same administration technique as the liposomal bupivacaine group, involving multiple small-volume injections to the paraspinal musculature spaced approximately 1 centimeter apart.",[19],"Drug: Bupivacaine Hydrochloride and Epinephrine Injection",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bupivacaine liposome injectable suspension","EXPAREL is a milky white too off-white aqueous suspension available as single-dose vials. Each mL contains 13.3 mg of bupivacaine, which is contained in multivesicular liposomes.",[9],[27],"EXPAREL",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Bupivacaine Hydrochloride and Epinephrine Injection","Sensorcaine-MPF with Epinephrine 1:200,000 is a clear, colorless to slightly yellow solution available as single-dose vials. Each mL contains bupivacaine hydrochloride, 0.005 mg epinephrine, and 0.5 mg sodium metabisulfite (antioxidant), and 0.2 mg anhydrous citric acid (stabilizer).",[15],[33],"Sensorcaine-MPF with Epinephrine 1:200,000",[35],{"name":36,"affiliation":5,"role":37},"Craig Birch, MD","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Sara Olenich, MS","CONTACT","(617) 355-6000",null,"sara.olenich@childrens.harvard.edu",{"name":46,"role":41,"phone":43,"phoneExt":43,"email":47},"Mikayla Flowers, MA","Mikayla.Flowers@childrens.harvard.edu",[49],{"facility":5,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-71.05977,42.35843,{"lat":60,"lon":59},[63,64,65,68,70],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},{"name":36,"role":37,"phone":43,"phoneExt":43,"email":43},{"name":66,"role":67,"phone":43,"phoneExt":43,"email":43},"Daniel Hedequist, MD","SUB_INVESTIGATOR",{"name":69,"role":67,"phone":43,"phoneExt":43,"email":43},"Timothy Hresko, MD",{"name":71,"role":67,"phone":43,"phoneExt":43,"email":43},"Grant Hogue, MD",{"type":37,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Craig Birch","Instructor of Orthopedic Surgery, Harvard Medical School","100552304","postoperative-pain-control-in-ais-using-liposomal-bupivacaine-vs-025-bupivacaine-with-epinephrine-100552304",false,"NCT06471348","Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine With Epinephrine","Postoperative Pain Control in AIS Using Liposomal Bupivacaine vs. 0.25% Bupivacaine","Inclusion Criteria:\n\n* ≥10 years old and ≤17 years old at assessment\n* Diagnosis of Adolescent Idiopathic Scoliosis\n* Planned surgical treatment of progressive spinal deformity with posterior spinal fusion\n\nExclusion Criteria:\n\n* Diagnosis of neuromuscular, syndromic, or congenital scoliosis\n* History of known allergy to local anesthesia\n* Chronic pre-operative opioid consumptions\n* Any other analgesic treatment for chronic pain before surgery\n* Psychiatric or neurological disorders\n* Cannot fluently read or speak English","ALL","10 Years","17 Years",{"count":86,"type":87},128,"ESTIMATED","INTERVENTIONAL",[90],"NA","A randomized controlled trial (RCT) investigating whether the local anesthetic injection of liposomal bupivacaine during posterior spinal fusion (PSF) for AIS is more effective in reducing acute postoperative opioid consumption compared to an equal volume injection of 0.25% bupivacaine with epinephrine for patients aged 10 to 17, with 128 patients randomly assigned to one of two arms: liposomal bupivacaine or 0.25% bupivacaine with epinephrine.",[93,94],"Post Operative Pain","Spinal Fusion","2025-10-21",{"date":97,"type":98},"2025-10-22","ACTUAL",{"date":100,"type":98},"2025-08-15",{"date":102,"type":87},"2028-08-31",{"name":5,"class":6},1]