Lumbar Spinal Fusion Surgery, Postoperative Pain, Surgical Blood Loss
Conditions
Keywords
Lumbar fusion, ESP block, PVI block, Intraoperative bleeding, Postoperative pain, WALANT, ropivacaine, epinephrine
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.
Detailed description
Lumbar fusion surgery treats degenerative disc disease, spondylolisthesis, and lumbar stenosis but carries high intraoperative bleeding risk (500-2000mL loss, 30% transfusion rate) and severe postoperative pain requiring systemic opioids. Periarticular vasoconstrictor infiltration (PVI), based on tumescent/WALANT principles, shows promise for hemostasis and analgesia by creating chemical tourniquet via epinephrine while blocking dorsal rami. Erector spinae plane (ESP) block is current standard but uses lower volumes (20mL/side) and different anatomic target. No prior RCTs compare PVI vs ESP head-to-head in lumbar fusion.
Interventions
PROCEDUREPeriarticular vasoconstrictor infiltration (PVI)
Periarticular Vasoconstrictor Infiltration (PVI) vs ESP Block: Multi-level infiltration technique (4 planes: retrolaminar, thoracolumbar fascia, supraspinous ligament, subcutaneous) vs single interfascial injection. High-volume (150-200mL bilateral, 20mL/vertebra) vs low-volume (40mL total). Multiple punctures (4-6 levels) vs single-level per side. Paravertebral chemical sympathectomy vs somatic nerve blockade. Targets surgical field bleeding control + analgesia vs thoracic dermatomal analgesia only.
PROCEDUREErector Spinae Block (ESP)
Erector Spinae Plane Block (ESP) vs PVI Infiltration: Single interfascial injection vs multi-level infiltration. Low-volume (20mL/side, 40mL total) vs high-volume (150-200mL). Single puncture per side at transverse processes vs multiple punctures (4-6 levels). Tip positioned above transverse process targeting erector spinae interfascial plane vs 4 anatomical planes (retrolaminar, fascia, ligament, subcutaneous). Somatic nerve blockade (thoracic dermatomes) vs paravertebral chemical sympathectomy + analgesia.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Due to fundamentally different technical approaches and volumes (PVI: 150-200mL bilateral multi-level periarticular vs ESP: 20mL/side single injection), blinding of performing anesthesiologists is not feasible. Patients are informed both techniques are standard care but not told their specific randomization. Outcome assessors (pain NRS evaluators, opioid consumption recorders, Fromme surgical field graders, data analysts) remain blinded to treatment allocation. Randomization envelopes opened intraoperatively by block-performing anesthesiologist only. Follow-up blinded per protocol
Intervention model description
Parallel Assignment, Randomized 1:1 Prospective RCT with 2 parallel groups: * Group 1 (PVI): Periarticular vasoconstrictor infiltration (150-200mL bilateral) * Group 2 (ESP): Erector spinae plane block (20mL/side bilateral) Randomization: StatsDirect, opaque sealed envelopes N=62 (31/arm), multicenter (Sant Pau Barcelona n=32, Quirón Murcia n=30) Single-blind (outcomes evaluator blinded) Intention-to-treat analysis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Surgical Bleeding | Day 0 | Total blood loss measured by aspiration from surgical field + weighed gauzes (after subtracting irrigation fluid volume) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain (NRS) | Day 1, day 2 | Numeric Rating Scale (0-10) for pain intensity |
| Opioid Consumption | Day 1, Day 2 | Total morphine equivalents (rescue doses) in first 48h |
| Fromme Surgical Field Grade | Day 0 | Surgical field bleeding quality (Grade 0-4) |
| Length of Hospital Stay | Perioperative | Days from surgery to hospital discharge |
Countries
Spain
Contacts
CONTACTMireia MD, PhD Rodriguez Prieto, Anesthesiologist
Outcome results
None listed