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

April 8, 2026 updated by: MIREIA RODRIGUEZ PRIETO, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • BARCELONA
      • Barcelona, BARCELONA, Spain, 08025
        • Hospital De La Santa Creu I Sant Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PVI Lumbar Fusion Patients
Patients treated with PVI during lumbar fusion surgery
Other: Periarticular Vasoconstrictor Infiltration
Ultrasound-guided infiltration of local anesthetic and epinephrine in deep and superficial periarticular planes before lumbar fusion surgery, as part of routine clinical care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss
Time Frame: Perioperative
Total volume aspirated (mL) from surgical suction, minus irrigation volume
Perioperative
Postoperative pain intensity
Time Frame: up to 24 hours
Numeric Verbal Scale (0-10) at 24 hours
up to 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: up to 24 hours
Total systemic opioid dose administered postoperatively
up to 24 hours
Opioid-related adverse effects
Time Frame: up to 24 hours
Incidence of nausea, vomiting, constipation, or sedation related to postoperative opioid use
up to 24 hours
Drain output
Time Frame: Perioperative
Total postoperative drain output (mL) recorded in surgical drains
Perioperative
Need for blood transfusion
Time Frame: Perioperative
Proportion of patients requiring perioperative red blood cell transfusion
Perioperative
Length of hospital stay
Time Frame: Perioperative
Number of days from surgery to hospital discharge
Perioperative
Block-related and postoperative complications
Time Frame: Perioperarive
Incidence of complications related to PVI or surgery (e.g., hypertension, arrhythmias, wound infection, hematoma, reoperation)
Perioperarive

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIBSP-EIP-2025-213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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