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

NCT07550114 | Recruiting DMC

• 1 other identifier: IBSP-IPV-2024-178
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgical Blood Loss; Postoperative Pain; Lumbar Spinal Fusion Surgery

Keywords

Lumbar fusion; ESP block; PVI block; Intraoperative bleeding; Postoperative pain; WALANT; ropivacaine; epinephrine

Outcome Measures

Primary Outcomes (1)

• Total Surgical Bleeding

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

  Day 0

Secondary Outcomes (4)

• Postoperative Pain (NRS)

  Day 1, day 2

• Opioid Consumption

  Day 1, Day 2

• Fromme Surgical Field Grade

  Day 0

• Length of Hospital Stay

  Perioperative

Study Arms (2)

Arm 1: PVI (Periarticular Vasoconstrictor Infiltration)

EXPERIMENTAL

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)

Arm 2: Erector Spinae Plane Block (ESP)

ACTIVE COMPARATOR

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)

Interventions

Periarticular vasoconstrictor infiltration (PVI) PROCEDURE

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.

Arm 1: PVI (Periarticular Vasoconstrictor Infiltration)

Erector Spinae Block (ESP) PROCEDURE

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.

Arm 2: Erector Spinae Plane Block (ESP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

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

Study Sites (2)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Hospital Quiron Murcia

Murcia, Murcia, 30011, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Blood Loss, Surgical; Pain, Postoperative

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Mireia MD, PhD Rodriguez Prieto, Anesthesiologist

CONTACT

677896054; mrodriguezpr@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to fundamentally different technical approaches and volumes (PVI: 150-200mL bilateral multi-level periarticular vs ESP: 20mL/side single injection), blinding of performing anesthesiologists is not feasible. Patients are informed both techniques are standard care but not told their specific randomization. Outcome assessors (pain NRS evaluators, opioid consumption recorders, Fromme surgical field graders, data analysts) remain blinded to treatment allocation. Randomization envelopes opened intraoperatively by block-performing anesthesiologist only. Follow-up blinded per protocol
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Principal Investigator, Anesthesiology and Pain Management Service

Model Details: Parallel Assignment, Randomized 1:1 Prospective RCT with 2 parallel groups: * Group 1 (PVI): Periarticular vasoconstrictor infiltration (150-200mL bilateral) * Group 2 (ESP): Erector spinae plane block (20mL/side bilateral) Randomization: StatsDirect, opaque sealed envelopes N=62 (31/arm), multicenter (Sant Pau Barcelona n=32, Quirón Murcia n=30) Single-blind (outcomes evaluator blinded) Intention-to-treat analysis

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 24, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): January 8, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)