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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.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• More than 18 years old.

• ASA I-III

• Scheduled primary spinal instrumentation surgery (lumbar/thoracolumbar fusion)

• Signed informed consent

Locations
Other Locations
Spain
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Quiron Murcia
NOT_YET_RECRUITING
Murcia
Contact Information
Primary
Mireia MD, PhD Rodriguez Prieto, Anesthesiologist
mrodriguezpr@santpau.cat
677896054
Time Frame
Start Date: 2026-01-08
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 62
Treatments
Experimental: Arm 1: PVI (Periarticular Vasoconstrictor Infiltration)
Once patient is anesthetized and positioned prone for surgery: Ultrasound probe is placed in sagittal plane to identify sacrum and laminae. Bilateral multilevel injections at instrumentation levels: retrolaminar space, thoracolumbar fascia, supraspinous ligament, and subcutaneous tissue at incision site. After negative blood aspiration, 20mL of local anesthetic and epinephrine are injected using a volum of 20ml/vertebra in deep planes, plus 20-40mL in subcutaneous tissue (total volum administered: 150-200mL) bilateral according to instrumentation levels. Multiple punctures required. PVI block is Performed by trained anesthesiologists in ultrasound guided regional anesthesia.
Active_comparator: Arm 2: Erector Spinae Plane Block (ESP)
Patient anesthetized and positioned prone: Ultrasound probe placed sagittal to identify sacrum/laminae, then shifted laterally to transverse processes. SonoTAP 21G needle inserted cranio-caudal at instrumentation levels locating the tip above transverse process. After negative blood aspiration, 20mL ropivacaine + epinephrine are injected interfascial between transverse process and erector spinae muscle. Confirmed spread under ultrasound. Bilateral administration. Multiple punctures if needed. Performed by trained anesthesiologists in reagional anesthesia.
Related Therapeutic Areas
Sponsors
Leads: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

This content was sourced from clinicaltrials.gov