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NCT Number: NCT07530237

Efficacy of Periarticular Vasoconstrictor Infiltration (PVI) in Reducing Bleeding and Postoperative Pain in Lumbar Fusion Surgery

This retrospective observational study evaluates the efficacy of periarticular vasoconstrictor infiltration (PVI) in reducing intraoperative bleeding and postoperative pain in adult patients undergoing lumbar fusion surgery at Hospital de la Santa Creu i Sant Pau (Barcelona, Spain) from November 2024 to October 2025. PVI, introduced recently as an alternative to erector spinae plane (ESP) block, involves ultrasound-guided infiltration of local anesthetic with epinephrine in deep and superficial periarticular planes before surgery. The study includes all consecutive cases meeting inclusion criteria (lumbar fusion in adults), excluding incomplete records (expected n=25).

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Key information

Conditions

Intraoperative Bleeding in Lumbar Spine Surgery Hemorrhage Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain in Lumbar Spine Surgery Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de La Santa Creu I Sant Pau

Barcelona, BARCELONA, 08025, Spain

About this study

Lumbar fusion surgery treats degenerative disc disease, spondylolisthesis, and lumbar stenosis when conservative management fails. It carries high risks of intraoperative bleeding (often requiring transfusion) and severe postoperative pain necessitating systemic opioids, impacting patient safety and recovery. Multimodal pain management and bleeding control are key challenges. Periarticular vasoconstrictor infiltration (PVI), inspired by tumescent anesthesia and WALANT techniques, has shown promise in reducing bleeding and improving analgesia in other orthopedic procedures. At Hospital de la Santa Creu i Sant Pau (Barcelona, Spain), PVI-ultrasound-guided infiltration of local anesthetic with epinephrine in deep/superficial periarticular planes was recently adopted preoperatively, replacing erector spinae plane (ESP) block, with promising clinical outcomes lacking formal retrospective analysis

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients undergoing lumbar fusion surgery who received PVI between November 2024-October 2025 at Hospital de Sant Pau

Exclusion criteria

  • Incomplete surgeries, incomplete clinical data, or poor quality anesthesia records.

Treatment and study plan

Periarticular Vasoconstrictor Infiltration

Other

Ultrasound-guided infiltration of local anesthetic and epinephrine in deep and superficial periarticular planes before lumbar fusion surgery, as part of routine clinical care.

Primary outcomes

  1. Intraoperative blood loss

    Time frame: Perioperative

    Total volume aspirated (mL) from surgical suction, minus irrigation volume

  2. Postoperative pain intensity

    Time frame: up to 24 hours

    Numeric Verbal Scale (0-10) at 24 hours

Secondary outcomes

  1. Postoperative opioid consumption

    Time frame: up to 24 hours

    Total systemic opioid dose administered postoperatively

  2. Opioid-related adverse effects

    Time frame: up to 24 hours

    Incidence of nausea, vomiting, constipation, or sedation related to postoperative opioid use

  3. Drain output

    Time frame: Perioperative

    Total postoperative drain output (mL) recorded in surgical drains

  4. Need for blood transfusion

    Time frame: Perioperative

    Proportion of patients requiring perioperative red blood cell transfusion

  5. Length of hospital stay

    Time frame: Perioperative

    Number of days from surgery to hospital discharge

  6. Block-related and postoperative complications

    Time frame: Perioperarive

    Incidence of complications related to PVI or surgery (e.g., hypertension, arrhythmias, wound infection, hematoma, reoperation)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Efficacy of Periarticular Vasoconstrictor Infiltration (PVI) in Reducing Bleeding and Postoperative Pain in Lumbar Fusion Surgery: Retrospective Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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