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PVI vs ESP Block for Reducing Bleeding and Postoperative Pain in Lumbar Fusion Surgery.

RecruitingNAAges 18 Years - anyAllFundació Institut de Recerca de l'Hospital de la …
NCT07550114 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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/side at transverse processes). Both groups receive standardized general anesthesia (TIVA), multimodal analgesia (dexamethasone, paracetamol, dexketoprofen/metamizole, 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 w

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📋 Eligibility rules (as published)
Inclusion Criteria: * More than 18 years old. * ASA I-III * Scheduled primary spinal instrumentation surgery (lumbar/thoracolumbar fusion) * Signed informed consent Exclusion Criteria: * Allergy/contraindication to study drugs (ropivacaine, epinephrine) * Coagulopathy. * Infection at block site * Neuromuscular disease affecting evaluation. * Chronic opioid use (\>30mg morphine equivalents/day) * Cognitive impairment preventing pain reporting. * Pregnancy
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What it tests

  • Periarticular vasoconstrictor infiltration (PVI)
  • Erector Spinae Block (ESP)
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Where

2 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Quiron Murcia
Murcia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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