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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Surgical Blood Loss; Lumbar Spinal Fusion Surgery
• Intervention / Treatment: Procedure: Periarticular vasoconstrictor infiltration (PVI); Procedure: Erector Spinae Block (ESP)

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.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mireia MD, PhD Rodriguez Prieto, Anesthesiologist; Phone Number: 677896054; Email: mrodriguezpr@santpau.cat

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08025
      • Recruiting
      • Hospital De La Santa Creu I Sant Pau
      • Contact: Mireia Rodriguez Prieto, Anesthesiologist; Phone Number: 677896054; Email: mrodriguezpr@santpau.cat
  • Murcia
    • Murcia, Murcia, Spain, 30011
      • Not yet recruiting
      • Hospital Quiron Murcia
      • Contact: Vicente MD Roqués Escolar, Anesthesiologist; Email: virroes@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: PVI (Periarticular Vasoconstrictor Infiltration); Once patient is anesthetized and positioned prone for surgery: Ultrasound probe is placed in sagittal plane to identify sacrum and laminae. Bilateral multilevel injections at instrumentation levels: retrolaminar space, thoracolumbar fascia, supraspinous ligament, and subcutaneous tissue at incision site. After negative blood aspiration, 20mL of local anesthetic and epinephrine are injected using a volum of 20ml/vertebra in deep planes, plus 20-40mL in subcutaneous tissue (total volum administered: 150-200mL) bilateral according to instrumentation levels. Multiple punctures required. PVI block is Performed by trained anesthesiologists in ultrasound guided regional anesthesia.	Procedure: Periarticular vasoconstrictor infiltration (PVI); 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.
Active Comparator: Arm 2: Erector Spinae Plane Block (ESP); Patient anesthetized and positioned prone: Ultrasound probe placed sagittal to identify sacrum/laminae, then shifted laterally to transverse processes. SonoTAP 21G needle inserted cranio-caudal at instrumentation levels locating the tip above transverse process. After negative blood aspiration, 20mL ropivacaine + epinephrine are injected interfascial between transverse process and erector spinae muscle. Confirmed spread under ultrasound. Bilateral administration. Multiple punctures if needed. Performed by trained anesthesiologists in reagional anesthesia.	Procedure: Erector Spinae Block (ESP); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Surgical Bleeding	Total blood loss measured by aspiration from surgical field + weighed gauzes (after subtracting irrigation fluid volume)	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain (NRS)	Numeric Rating Scale (0-10) for pain intensity	Day 1, day 2
Opioid Consumption	Total morphine equivalents (rescue doses) in first 48h	Day 1, Day 2
Fromme Surgical Field Grade	Surgical field bleeding quality (Grade 0-4)	Day 0
Length of Hospital Stay	Days from surgery to hospital discharge	Perioperative

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2026
• Primary Completion (Estimated): January 8, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 19, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ropivacaine; Postoperative pain; epinephrine; ESP block; Lumbar fusion; WALANT; Intraoperative bleeding; PVI block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Hemorrhage; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Blood Loss, Surgical
• Other Study ID Numbers: IBSP-IPV-2024-178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The identified summary results will be published in peer-reviewed journal (Anesthesiology/Regional Anesthesia). Individual participant data sharing not planned per standard practice for single-center surgical RCTs.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No