- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07530237
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
Active, not recruiting
Conditions
Intervention / Treatment
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
Observational
Enrollment (Estimated)
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
PVI Lumbar Fusion Patients
Patients treated with PVI during lumbar fusion surgery
|
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
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
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.
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)
March 12, 2026
Primary Completion (Estimated)
April 12, 2026
Study Completion (Estimated)
April 30, 2026
Study Registration Dates
First Submitted
March 23, 2026
First Submitted That Met QC Criteria
April 8, 2026
First Posted (Actual)
April 15, 2026
Study Record Updates
Last Update Posted (Actual)
April 15, 2026
Last Update Submitted That Met QC Criteria
April 8, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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