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Surgical Blood LossNCT07550114

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

A study testing Periarticular vasoconstrictor infiltration (PVI) and Erector Spinae Block (ESP) in people with Surgical Blood Loss and Postoperative Pain, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Periarticular vasoconstrictor infiltration (PVI) and Erector Spinae Block (ESP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
2 sitesSpain
Study dates
8 Jan 2026to 1 Mar 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • More than 18 years old.
  • ASA I-III
  • Scheduled primary spinal instrumentation surgery (lumbar/thoracolumbar fusion)
  • Signed informed consent

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Mireia MD, PhD Rodriguez Prieto, Anesthesiologist contact

677896054

mrodriguezpr@santpau.cat

Spain2 sites, 2 recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

    Mireia Rodriguez Prieto, Anesthesiologist, 677896054, mrodriguezpr@santpau.cat

    Recruiting

  • Hospital Quiron Murcia

    Murcia, Murcia, 30011

    Vicente MD Roqués Escolar, Anesthesiologist, virroes@gmail.com

    Not yet recruiting

Other trials in Spain

About this study

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.

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.

Read the 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.

Being tested
Periarticular vasoconstrictor infiltration (PVI), Erector Spinae Block (ESP)
Keywords
Lumbar fusion, ESP block, PVI block, Intraoperative bleeding, Postoperative pain, WALANT, ropivacaine, epinephrine
Medical subject headings
Blood Loss, Surgical, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Periarticular vasoconstrictor infiltration (PVI)Procedure or 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 or 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.

Study groups in NCT07550114
Study groupRoleWhat they receive
Arm 1: PVI (Periarticular Vasoconstrictor Infiltration)ExperimentalOnce 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.
Receives: Procedure: Periarticular vasoconstrictor infiltration (PVI)
Arm 2: Erector Spinae Plane Block (ESP)Active comparatorPatient 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.
Receives: Procedure: Erector Spinae Block (ESP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Surgical Bleeding

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

    Measured: Day 0

Secondary outcomes (4)

  1. Postoperative Pain (NRS)

    Numeric Rating Scale (0-10) for pain intensity

    Measured: Day 1, day 2

  2. Opioid Consumption

    Total morphine equivalents (rescue doses) in first 48h

    Measured: Day 1, Day 2

  3. Fromme Surgical Field Grade

    Surgical field bleeding quality (Grade 0-4)

    Measured: Day 0

  4. Length of Hospital Stay

    Days from surgery to hospital discharge

    Measured: Perioperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2026
  2. Study start8 Jan 2026
  3. Primary completion8 Jan 2028 (estimated)
  4. Study completion1 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07550114
Sponsor's protocol ID
IBSP-IPV-2024-178
Status last verified
Apr 2026
First submitted
10 Apr 2026
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Periarticular vasoconstrictor infiltration (PVI) and Erector Spinae Block (ESP) in people with Surgical Blood Loss and Postoperative Pain, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mireia MD, PhD Rodriguez Prieto, Anesthesiologist (677896054, mrodriguezpr@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Surgical Bleeding (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07550114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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