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Набира участници Не е приложимо NCT07550114

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

Не е приложима фаза (напр. обсервационно)
Заболявания: Surgical Blood Loss Postoperative Pain Lumbar Spinal Fusion Surgery

Спонсор: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Налично на: БГ
Обобщение
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 weight). Secondary outcomes: Fromme surgical field scale, pain (NRS at REA discharge/24h/48h), opioid consumption (morphine equivalents), PONV/antiemetic use, drain output, hospital stay, patient satisfaction. N=62 patients (31/arm). Blinded outcome assessment.
Описание
Lumbar fusion surgery treats degenerative disc disease, spondylolisthesis, and lumbar stenosis but carries high intraoperative bleeding risk (500-2000mL loss, 30% transfusion rate) and severe postoperative pain requiring systemic opioids. Periarticular vasoconstrictor infiltration (PVI), based on tumescent/WALANT principles, shows promise for hemostasis and analgesia by creating chemical tourniquet via epinephrine while blocking dorsal rami. Erector spinae plane (ESP) block is current standard but uses lower volumes (20mL/side) and different anatomic target. No prior RCTs compare PVI vs ESP head-to-head in lumbar fusion.
Кой може да участва
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
Интервенции
Periarticular vasoconstrictor infiltration (PVI)
PROCEDURE
Erector Spinae Block (ESP)
PROCEDURE
Места на провеждане 2
Испания (2)
Hospital de la Santa Creu i Sant Pau
Barcelona , Barcelona
Mireia Rodriguez Prieto, Anesthesiologist
Hospital Quiron Murcia
Murcia , Murcia
NOT_YET_RECRUITING
Vicente MD Roqués Escolar, Anesthesiologist
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
08.01.2026
Крайна дата
01.03.2028
Регистрационен номер
NCT07550114
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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