NCT07550114 PVI vs ESP Block for Reducing Bleeding and Postoperative Pain in Lumbar Fusion Surgery.
| NCT ID | NCT07550114 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Condition | Surgical Blood Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2026-01-08 |
| Primary Completion | 2028-01-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2026-01-08 with a primary completion date of 2028-01-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized controlled trial compares periarticular vasoconstrictor infiltration (PVI) versus erector spinae plane block (ESP) to reduce bleeding and postoperative pain in adults undergoing lumbar fusion surgery (up to 3 levels). Patients are randomly assigned 1:1 to receive ultrasound-guided ropivacaine 0.2% + epinephrine 1:200,000: PVI (150-200mL bilateral in retrolaminar, thoracolumbar fascia, supraspinous ligament, subcutaneous planes) or ESP (20mL/side at transverse processes). Both groups receive standardized general anesthesia (TIVA), multimodal analgesia (dexamethasone, paracetamol, dexketoprofen/metamizole, ketamine, magnesium), and tranexamic acid. Multicenter study: Hospital de la Santa Creu i Sant Pau (Barcelona, 32 patients) and Hospital Quirón Salud Murcia (30 patients). Primary outcome: intraoperative blood loss (surgical aspirate minus irrigation + gravimetric gauze weight). Secondary outcomes: Fromme surgical field scale, pain (NRS at REA discharge/24h/48h), opioid consumption (morphine equivalents), PONV/antiemetic use, drain output, hospital stay, patient satisfaction. N=62 patients (31/arm). Blinded outcome assessment.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07550114 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgical Blood Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07550114 currently recruiting?
Yes, NCT07550114 is actively recruiting participants. Contact the research team at mrodriguezpr@santpau.cat for enrollment information.
Where is the NCT07550114 trial being conducted?
This trial is being conducted at Barcelona, Spain, Murcia, Spain.
Who is sponsoring the NCT07550114 clinical trial?
NCT07550114 is sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. The trial plans to enroll 62 participants.