Intraoperative Bleeding in Lumbar Spine SurgeryNCT07530237
Efficacy of Periarticular Vasoconstrictor Infiltration (PVI) in Reducing Bleeding and Postoperative Pain in Lumbar Fusion Surgery
An observational study of Intraoperative Bleeding in Lumbar Spine Surgery and Postoperative Pain in Lumbar Spine Surgery, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Bleeding in Lumbar Spine Surgery, Postoperative Pain in Lumbar Spine Surgery
- What is being tested?
- Periarticular Vasoconstrictor Infiltration
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 12 Mar 2026to 30 Apr 2026
- Phase
- Observational
- 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
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.
Who may be able to join
- Adult patients undergoing lumbar fusion surgery who received PVI between November 2024-October 2025 at Hospital de Sant Pau
Who cannot join
- Incomplete surgeries, incomplete clinical data, or poor quality anesthesia records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Conditions
- Intraoperative Bleeding in Lumbar Spine Surgery, Postoperative Pain in Lumbar Spine Surgery
- Being tested
- Periarticular Vasoconstrictor Infiltration
- Keywords
- lumbar fusion, Periarticular vasoconstrictor infiltration (PVI), Bleeding, Postoperative pain, Erector spinae block (ESP), Regional anesthesia
- Medical subject headings
- Hemorrhage, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periarticular Vasoconstrictor InfiltrationOther
Ultrasound-guided infiltration of local anesthetic and epinephrine in deep and superficial periarticular planes before lumbar fusion surgery, as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| PVI Lumbar Fusion Patients | Patients treated with PVI during lumbar fusion surgery Receives: Other: Periarticular Vasoconstrictor Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Total volume aspirated (mL) from surgical suction, minus irrigation volume
Measured: Perioperative
Postoperative pain intensity
Numeric Verbal Scale (0-10) at 24 hours
Measured: up to 24 hours
Secondary outcomes (6)
Postoperative opioid consumption
Total systemic opioid dose administered postoperatively
Measured: up to 24 hours
Opioid-related adverse effects
Incidence of nausea, vomiting, constipation, or sedation related to postoperative opioid use
Measured: up to 24 hours
Drain output
Total postoperative drain output (mL) recorded in surgical drains
Measured: Perioperative
Need for blood transfusion
Proportion of patients requiring perioperative red blood cell transfusion
Measured: Perioperative
Length of hospital stay
Number of days from surgery to hospital discharge
Measured: Perioperative
Block-related and postoperative complications
Incidence of complications related to PVI or surgery (e.g., hypertension, arrhythmias, wound infection, hematoma, reoperation)
Measured: Perioperarive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start12 Mar 2026
- Primary completion12 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Bleeding in Lumbar Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MIREIA RODRIGUEZ PRIETO, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530237
- Sponsor's protocol ID
- IIBSP-EIP-2025-213
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Periarticular Vasoconstrictor Infiltration (PVI) in Reducing Bleeding and Postoperative Pain in Lumbar Fusion Surgery: Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT07530237
- Acronym / sponsor ID
- IIBSP-EIP-2025-213
- Conditions
- Intraoperative Bleeding in Lumbar Spine Surgery, Postoperative Pain in Lumbar Spine Surgery
- Keywords
- lumbar fusion, Periarticular vasoconstrictor infiltration (PVI), Bleeding, Postoperative pain, Erector spinae block (ESP), Regional anesthesia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 12 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PVI Lumbar Fusion Patients | – | Other: Periarticular Vasoconstrictor InfiltrationPatients treated with PVI during lumbar fusion surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients undergoing lumbar fusion surgery who received PVI between November 2024-October 2025 at Hospital de Sant Pau
Key exclusion criteria (1 listed)
- Incomplete surgeries, incomplete clinical data, or poor quality anesthesia records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periarticular Vasoconstrictor InfiltrationUltrasound-guided infiltration of local anesthetic and epinephrine in deep and superficial periarticular planes before lumbar fusion surgery, as part of routine clinical care. | Other | PVI Lumbar Fusion Patients |
Primary outcome
Intraoperative blood loss
Time frame: Perioperative
Total volume aspirated (mL) from surgical suction, minus irrigation volume
Postoperative pain intensity
Time frame: up to 24 hours
Numeric Verbal Scale (0-10) at 24 hours
6 secondary outcomes
Postoperative opioid consumption
Time frame: up to 24 hours
Opioid-related adverse effects
Time frame: up to 24 hours
Drain output
Time frame: Perioperative
Need for blood transfusion
Time frame: Perioperative
Length of hospital stay
Time frame: Perioperative
Block-related and postoperative complications
Time frame: Perioperarive
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Bleeding in Lumbar Spine Surgery and Postoperative Pain in Lumbar Spine Surgery, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 15 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 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: Perioperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2026.