NCT07530237

Brief Summary

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2026

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

March 23, 2026

Last Update Submit

April 8, 2026

Conditions

Keywords

lumbar fusionPeriarticular vasoconstrictor infiltration (PVI)BleedingPostoperative painErector spinae block (ESP)Regional anesthesia

Outcome Measures

Primary Outcomes (2)

  • Intraoperative blood loss

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

    Perioperative

  • Postoperative pain intensity

    Numeric Verbal Scale (0-10) at 24 hours

    up to 24 hours

Secondary Outcomes (6)

  • Postoperative opioid consumption

    up to 24 hours

  • Opioid-related adverse effects

    up to 24 hours

  • Drain output

    Perioperative

  • Need for blood transfusion

    Perioperative

  • Length of hospital stay

    Perioperative

  • +1 more secondary outcomes

Study Arms (1)

PVI Lumbar Fusion Patients

Patients treated with PVI during lumbar fusion surgery

Other: Periarticular Vasoconstrictor Infiltration

Interventions

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

PVI Lumbar Fusion Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (18-90 years) undergoing elective lumbar fusion surgery for degenerative disc disease, spondylolisthesis, or lumbar stenosis at Hospital de la Santa Creu i Sant Pau (Barcelona). Typical characteristics: mixed gender, ASA I-III, comorbidities common in orthopedic spine population.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de La Santa Creu I Sant Pau

Barcelona, BARCELONA, 08025, Spain

Location

MeSH Terms

Conditions

HemorrhagePain, Postoperative

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist specialized in Regional and Orthopedic Anesthesia at Hospital de Sant Pau, Barcelona"

Study Record Dates

First Submitted

March 23, 2026

First Posted

April 15, 2026

Study Start

March 12, 2026

Primary Completion

April 12, 2026

Study Completion

April 30, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations