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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: PVI (Periarticular Vasoconstrictor Infiltration) | Experimental | 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. |
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| Arm 2: Erector Spinae Plane Block (ESP) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Periarticular vasoconstrictor infiltration (PVI) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Surgical Bleeding | Total blood loss measured by aspiration from surgical field + weighed gauzes (after subtracting irrigation fluid volume) | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain (NRS) | Numeric Rating Scale (0-10) for pain intensity | Day 1, day 2 |
| Opioid Consumption | Total morphine equivalents (rescue doses) in first 48h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mireia MD, PhD Rodriguez Prieto, Anesthesiologist | Contact | 677896054 | mrodriguezpr@santpau.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Barcelona | 08025 | Spain |
The identified summary results will be published in peer-reviewed journal (Anesthesiology/Regional Anesthesia). Individual participant data sharing not planned per standard practice for single-center surgical RCTs.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study protocol and Statistical Analysis Plan- English versio |
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Parallel Assignment, Randomized 1:1
Prospective RCT with 2 parallel groups:
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
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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
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| Erector Spinae Block (ESP) | Procedure | 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. |
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| Day 1, Day 2 |
| Fromme Surgical Field Grade | Surgical field bleeding quality (Grade 0-4) | Day 0 |
| Length of Hospital Stay | Days from surgery to hospital discharge | Perioperative |
| Hospital Quiron Murcia | Not yet recruiting | Murcia | Murcia | 30011 | Spain |
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| Jul 18, 2025 |
| Mar 17, 2026 |
| Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study protocol english version | Jul 18, 2025 | Apr 19, 2026 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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