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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

More than 18 years old.

ASA I-III

Scheduled primary spinal instrumentation surgery (lumbar/thoracolumbar fusion)

Signed informed consent

Disqualifiers

Allergy/contraindication to study drugs (ropivacaine, epinephrine)

Coagulopathy.

Infection at block site

Neuromuscular disease affecting evaluation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Periarticular vasoconstrictor infiltration (PVI)

    Procedure/Surgery

    Periarticular Vasoconstrictor Infiltration (PVI) vs ESP Block: Multi-level infiltration technique (4 planes: retrolaminar, thoracolumbar fascia, supraspinous ligament, subcutaneous) vs single interfascial injection. High-volume (150-200mL bilateral, 20mL/vertebra) vs low-volume (40mL total). Multiple punctures (4-6 levels) vs single-level per side. Paravertebral chemical sympathectomy vs somatic nerve blockade. Targets surgical field bleeding control + analgesia vs thoracic dermatomal analgesia only.

  • Erector Spinae Block (ESP)

    Procedure/Surgery

    Erector Spinae Plane Block (ESP) vs PVI Infiltration: Single interfascial injection vs multi-level infiltration. Low-volume (20mL/side, 40mL total) vs high-volume (150-200mL). Single puncture per side at transverse processes vs multiple punctures (4-6 levels). Tip positioned above transverse process targeting erector spinae interfascial plane vs 4 anatomical planes (retrolaminar, fascia, ligament, subcutaneous). Somatic nerve blockade (thoracic dermatomes) vs paravertebral chemical sympathectomy + analgesia.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Arm 1: PVI (Periarticular Vasoconstrictor Infiltration)Experimental treatment 1 intervention
Group B: Arm 2: Erector Spinae Plane Block (ESP)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total Surgical Bleeding

Total blood loss measured by aspiration from surgical field + weighed gauzes (after subtracting irrigation fluid volume)

Time frame
Day 0

Secondary outcomes

1

Postoperative Pain (NRS)

Numeric Rating Scale (0-10) for pain intensity

Time frame
Day 1, day 2
2

Opioid Consumption

Total morphine equivalents (rescue doses) in first 48h

Time frame
Day 1, Day 2
3

Fromme Surgical Field Grade

Surgical field bleeding quality (Grade 0-4)

Time frame
Day 0
4

Length of Hospital Stay

Days from surgery to hospital discharge

Time frame
Perioperative

Other outcomes

Sponsors and contacts

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