Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07550114

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

Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2026-04-24

62

Participants Needed

2

Research Sites

111 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • More than 18 years old.
  • ASA physical status I to III.
  • Scheduled for primary lumbar or thoracolumbar spinal fusion surgery.
  • Signed informed consent given.
Not Eligible

You will not qualify if you...

  • Allergy or contraindication to ropivacaine or epinephrine.
  • Coagulopathy.
  • Infection at the site of the nerve block.
  • Neuromuscular disease affecting pain evaluation.
  • Chronic opioid use exceeding 30 mg morphine equivalents per day.
  • Cognitive impairment preventing pain reporting.
  • Pregnancy.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain, 08025

Actively Recruiting

2

Hospital Quiron Murcia

Murcia, Murcia, Spain, 30011

Not Yet Recruiting

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Research Team

M

Mireia MD, PhD Rodriguez Prieto, Anesthesiologist

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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