PVI vs ESP Block for Reducing Bleeding and Postoperative Pain in Lumbar Fusion Surgery.
Recruiting now · Not applicable
Conditions studied: Surgical Blood Loss, Postoperative Pain, Lumbar Spinal Fusion Surgery
In brief
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.
Key facts
- Study ID
- NCT07550114
- Run by
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- People needed
- 62
- Starts
- 2026-01-08
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- More than 18 years old.
- ASA I-III
- Scheduled primary spinal instrumentation surgery (lumbar/thoracolumbar fusion)
- Signed informed consent
You may not qualify if…
- 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
Where it is running
- Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain (enrolling)
- Hospital Quiron Murcia — Murcia, Murcia, Spain
Full record on ClinicalTrials.gov
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