Comparing periarticular vasoconstrictor infiltration and erector spinae plane block to reduce bleeding and pain in lumbar fusion
EFFICACY OF PERIARTICULAR VASOCONSTRICTOR INFILTRATION (PVI) VERSUS ERECTOR SPINAE PLANE BLOCK (ESP) IN REDUCING BLEEDING AND POSTOPERATIVE PAIN CONTROL IN LUMBAR FUSION SURGERY: RANDOMIZED CLINICAL TRIAL.
This trial will try periarticular vasoconstrictor infiltration versus erector spinae plane block to see if one reduces blood loss and postoperative pain in adults having lumbar fusion surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Locations | 2 sites (Barcelona, Barcelona and 1 other locations) |
| Trial ID | NCT07550114 on ClinicalTrials.gov |
What this trial studies
This is a randomized 1:1 multicenter trial enrolling adults undergoing primary lumbar or thoracolumbar fusion (up to three levels) at two hospitals in Spain. Participants receive ultrasound-guided ropivacaine 0.2% with epinephrine either as a high-volume periarticular vasoconstrictor infiltration (PVI) in multiple tissue planes or as a standard erector spinae plane (ESP) block (20 mL per side), with both groups managed under standardized general anesthesia, multimodal analgesia, and tranexamic acid. The primary outcome is intraoperative blood loss measured by surgical aspirate minus irrigation plus gravimetric gauze weight; secondary outcomes include surgical field quality, pain scores at multiple time points, and opioid consumption. The trial enrolls about 62 patients across Hospital de la Santa Creu i Sant Pau (Barcelona) and Hospital Quirón Salud Murcia (Murcia).
Who should consider this trial
Good fit: Adults (over 18) with ASA I–III scheduled for primary lumbar or thoracolumbar fusion who can provide informed consent and are not on high-dose chronic opioids are ideal candidates.
Not a fit: Patients with contraindications such as allergy to study drugs, coagulopathy, infection at the block site, neuromuscular disease affecting assessment, chronic high-dose opioid use, cognitive impairment, or pregnancy are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the preferred technique could lower intraoperative bleeding and postoperative pain, potentially reducing transfusions and opioid needs.
How similar studies have performed: Erector spinae plane blocks have supportive evidence for postoperative analgesia, PVI is a promising high-volume vasoconstrictive approach based on WALANT principles, and there are no prior randomized head-to-head trials comparing PVI versus ESP in lumbar fusion.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * More than 18 years old. * ASA I-III * Scheduled primary spinal instrumentation surgery (lumbar/thoracolumbar fusion) * Signed informed consent Exclusion Criteria: * Allergy/contraindication to study drugs (ropivacaine, epinephrine) * Coagulopathy. * Infection at block site * Neuromuscular disease affecting evaluation. * Chronic opioid use (\>30mg morphine equivalents/day) * Cognitive impairment preventing pain reporting. * Pregnancy
Where this trial is running
Barcelona, Barcelona and 1 other locations
- Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain (Recruiting)
- Hospital Quiron Murcia — Murcia, Murcia, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: Mireia MD, PhD Rodriguez Prieto, Anesthesiologist
- Email: mrodriguezpr@santpau.cat
- Phone: 677896054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.