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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Total Surgical Bleeding
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 18 years old.
- •ASA I-III
- •Scheduled primary spinal instrumentation surgery (lumbar/thoracolumbar fusion)
- •Signed informed consent
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Periarticular vasoconstrictor infiltration (PVI) (Procedure)
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.
干预措施: Erector Spinae Block (ESP) (Procedure)
结局指标
主要结局
Total Surgical Bleeding
时间窗: Day 0
Total blood loss measured by aspiration from surgical field + weighed gauzes (after subtracting irrigation fluid volume)
次要结局
- Postoperative Pain (NRS)(Day 1, day 2)
- Opioid Consumption(Day 1, Day 2)
- Fromme Surgical Field Grade(Day 0)
- Length of Hospital Stay(Perioperative)
研究者
MIREIA RODRIGUEZ PRIETO
Coordinating Principal Investigator, Anesthesiology and Pain Management Service
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau