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

ClinicalTrials.gov ID

NCT07550114

Lead Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

62Estimated

Last Update Posted

Apr 24, 2026Actual

Start Date

Jan 8, 2026Actual

Primary Completion Date

Jan 8, 2028Estimated

Completion Date

Mar 1, 2028Estimated

Official Title

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.

Brief Summary

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.

Detailed Description

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.

• Surgical Blood Loss
• Postoperative Pain
• Lumbar Spinal Fusion Surgery

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

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauOTHER

virroes@gmail.com

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