[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635240":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":68,"collaborators":26,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":26,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":26,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: PVI (Periarticular Vasoconstrictor Infiltration)","EXPERIMENTAL","Once patient is anesthetized and positioned prone for surgery: Ultrasound probe is placed in sagittal plane to identify sacrum and laminae. Bilateral multilevel injections at instrumentation levels: retrolaminar space, thoracolumbar fascia, supraspinous ligament, and subcutaneous tissue at incision site. After negative blood aspiration, 20mL of local anesthetic and epinephrine are injected using a volum of 20ml\u002Fvertebra in deep planes, plus 20-40mL in subcutaneous tissue (total volum administered: 150-200mL) bilateral according to instrumentation levels. Multiple punctures required. PVI block is Performed by trained anesthesiologists in ultrasound guided regional anesthesia.",[13],"Procedure: Periarticular vasoconstrictor infiltration (PVI)",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2: Erector Spinae Plane Block (ESP)","ACTIVE_COMPARATOR","Patient anesthetized and positioned prone: Ultrasound probe placed sagittal to identify sacrum\u002Flaminae, then shifted laterally to transverse processes. SonoTAP 21G needle inserted cranio-caudal at instrumentation levels locating the tip above transverse process. After negative blood aspiration, 20mL ropivacaine + epinephrine are injected interfascial between transverse process and erector spinae muscle. Confirmed spread under ultrasound. Bilateral administration. Multiple punctures if needed. Performed by trained anesthesiologists in reagional anesthesia.",[19],"Procedure: Erector Spinae Block (ESP)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Periarticular vasoconstrictor infiltration (PVI)","Periarticular Vasoconstrictor Infiltration (PVI) vs ESP Block: Multi-level infiltration technique (4 planes: retrolaminar, thoracolumbar fascia, supraspinous ligament, subcutaneous) vs single interfascial injection. High-volume (150-200mL bilateral, 20mL\u002Fvertebra) vs low-volume (40mL total). Multiple punctures (4-6 levels) vs single-level per side. Paravertebral chemical sympathectomy vs somatic nerve blockade. Targets surgical field bleeding control + analgesia vs thoracic dermatomal analgesia only.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Erector Spinae Block (ESP)","Erector Spinae Plane Block (ESP) vs PVI Infiltration: Single interfascial injection vs multi-level infiltration. Low-volume (20mL\u002Fside, 40mL total) vs high-volume (150-200mL). Single puncture per side at transverse processes vs multiple punctures (4-6 levels). Tip positioned above transverse process targeting erector spinae interfascial plane vs 4 anatomical planes (retrolaminar, fascia, ligament, subcutaneous). Somatic nerve blockade (thoracic dermatomes) vs paravertebral chemical sympathectomy + analgesia.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Mireia MD, PhD Rodriguez Prieto, Anesthesiologist","CONTACT","677896054","mrodriguezpr@santpau.cat",[38,54],{"facility":39,"status":40,"city":41,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Hospital de la Santa Creu i Sant Pau","RECRUITING","Barcelona","08025","Spain","ES",{"type":46,"coordinates":47},"Point",[48,49],2.15899,41.38879,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":35,"phoneExt":26,"email":36},"Mireia Rodriguez Prieto, Anesthesiologist",{"facility":55,"status":56,"city":57,"state":57,"zip":58,"country":43,"countryCode":44,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Hospital Quiron Murcia","NOT_YET_RECRUITING","Murcia","30011",{"type":46,"coordinates":60},[61,62],-1.13004,37.98704,{"lat":62,"lon":61},[65],{"name":66,"role":34,"phone":26,"phoneExt":26,"email":67},"Vicente MD Roqués Escolar, Anesthesiologist","virroes@gmail.com",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","MIREIA RODRIGUEZ PRIETO","Coordinating Principal Investigator, Anesthesiology and Pain Management Service","100635240","pvi-vs-esp-block-for-reducing-bleeding-and-postoperative-pain-in-lumbar-fusion-surgery-100635240",false,"NCT07550114","PVI vs ESP Block for Reducing Bleeding and Postoperative Pain in Lumbar Fusion Surgery.","EFFICACY OF PERIARTICULAR VASOCONSTRICTOR INFILTRATION (PVI) VERSUS ERECTOR SPINAE PLANE BLOCK (ESP) IN REDUCING BLEEDING AND POSTOPERATIVE PAIN CONTROL IN LUMBAR FUSION SURGERY: RANDOMIZED CLINICAL TRIAL.","Inclusion Criteria:\n\n* More than 18 years old.\n* ASA I-III\n* Scheduled primary spinal instrumentation surgery (lumbar\u002Fthoracolumbar fusion)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Allergy\u002Fcontraindication to study drugs (ropivacaine, epinephrine)\n* Coagulopathy.\n* Infection at block site\n* Neuromuscular disease affecting evaluation.\n* Chronic opioid use (\\>30mg morphine equivalents\u002Fday)\n* Cognitive impairment preventing pain reporting.\n* Pregnancy","ALL","18 Years",{"count":82,"type":83},62,"ESTIMATED","INTERVENTIONAL",[86],"NA","This randomized controlled trial compares periarticular vasoconstrictor infiltration (PVI) versus erector spinae plane block (ESP) to reduce bleeding and postoperative pain in adults undergoing lumbar fusion surgery (up to 3 levels). Patients are randomly assigned 1:1 to receive ultrasound-guided ropivacaine 0.2% + epinephrine 1:200,000: PVI (150-200mL bilateral in retrolaminar, thoracolumbar fascia, supraspinous ligament, subcutaneous planes) or ESP (20mL\u002Fside at transverse processes). Both groups receive standardized general anesthesia (TIVA), multimodal analgesia (dexamethasone, paracetamol, dexketoprofen\u002Fmetamizole, ketamine, magnesium), and tranexamic acid. Multicenter study: Hospital de la Santa Creu i Sant Pau (Barcelona, 32 patients) and Hospital Quirón Salud Murcia (30 patients). Primary outcome: intraoperative blood loss (surgical aspirate minus irrigation + gravimetric gauze weight). Secondary outcomes: Fromme surgical field scale, pain (NRS at REA discharge\u002F24h\u002F48h), opioid consumption (morphine equivalents), PONV\u002Fantiemetic use, drain output, hospital stay, patient satisfaction. N=62 patients (31\u002Farm). Blinded outcome assessment.",[89,90,91],"Surgical Blood Loss","Postoperative Pain","Lumbar Spinal Fusion Surgery",[93,94,95,96,97,98,99,100],"Lumbar fusion","ESP block","PVI block","Intraoperative bleeding","Postoperative pain","WALANT","ropivacaine","epinephrine","2026-04-19",{"date":103,"type":104},"2026-04-24","ACTUAL",{"date":106,"type":104},"2026-01-08",{"date":108,"type":83},"2028-03-01",{"name":5,"class":6},2]