Efficacy of Ultrasound-Guided Retrolaminar Block Combined With Standard Multimodal Analgesia for Postoperative Pain Management in Lumbar Spine Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Total postoperative opioid consumption
研究概览
简要总结
This randomized controlled trial evaluates the effectiveness of ultrasound-guided retrolaminar nerve block in addition to standard multimodal analgesia for postoperative pain management in patients undergoing lumbar spine surgery. Fifty patients will be randomly assigned to receive either the retrolaminar block combined with standard pain management or standard pain management alone. The primary outcome is total opioid consumption in the first 24 hours after surgery. Secondary outcomes include pain intensity at multiple time points, time to first rescue analgesia, duration of sensory block, incidence of postoperative nausea and vomiting, length of hospital stay, patient satisfaction, and chronic pain development at 3 and 6 months follow-up.
详细描述
BACKGROUND: Lumbar spine surgery is associated with significant postoperative pain, which can delay recovery and increase complications. Regional anesthesia techniques, specifically retrolaminar blocks, may provide superior analgesia compared to systemic opioids alone.
STUDY DESIGN: This is a prospective, randomized, controlled trial conducted at Clínica Universidad de Los Andes, Chile. Patients will be allocated using variable block randomization (block sizes 4 and 6) in a 1:1 ratio.
INTERVENTIONS: All patients will receive standardized general anesthesia (Propofol, Remifentanil, Rocuronium) and multimodal analgesia including paracetamol, metamizol, ketorolac, morphine, and pregabalin. The intervention group will additionally receive bilateral ultrasound-guided retrolaminar blocks with ropivacaine 0.5% (20 ml per side) at the end of surgery.
OUTCOMES: Primary outcome is cumulative morphine consumption via patient-controlled analgesia (PCA) during the first 24 postoperative hours. Secondary outcomes include pain scores (VAS 0-10) at 0, 6, 12, 24, 48, and 72 hours; time to first rescue analgesia; duration of sensory block; incidence of nausea/vomiting; hospital length of stay; time to ambulation; sleep quality; patient satisfaction; adverse events; and development of chronic pain at 3 and 6 months.
SAMPLE SIZE: 50 patients (25 per group) provides 80% power to detect a clinically significant difference in opioid consumption.
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
Outcomes assessors (including pain evaluators and data collectors) will be blinded to group allocation.
The anesthesiologist performing the intervention and the patient cannot be blinded due to the nature of the procedure (performance of nerve block).
Postoperative care providers will also be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-80 years
- •Scheduled for elective lumbar spine surgery (with instrumentation)
- •American Society of Anesthesiologists (ASA) physical status I-III
- •Willing and able to provide written informed consent
- •Able to use patient-controlled analgesia (PCA) device
排除标准
- •Refusal to participate in the study
- •Known allergy to local anesthetics (bupivacaine - levobupivacaine - lidocaine) or any study medication
- •Contraindication to regional anesthesia (infection at injection site, coagulopathy)
- •Chronic opioid use (daily use for >3 months prior to surgery)
- •Severe psychiatric disorder that precludes informed consent
- •Emergency surgery
- •Diabetes mellitus with preoperative glucose >180 mg/dl
- •Pregnancy or breastfeeding
- •Body mass index (BMI) >40 kg/m²
- •Reoperation or revision of the same level of previous spinal surgery
研究组 & 干预措施
Retrolaminar Block & Standard Analgesia
Patients receive bilateral ultrasound-guided retrolaminar blocks with Bupivacaine 0.25% and Epinephrine 50mcg (15 ml total volume per side) before surgery, along with standard multimodal analgesia.
干预措施: Ultrasound-Guided Retrolaminar Block (Procedure)
Standard Analgesia Only
Patients receive standard multimodal analgesia without regional anesthesia block.
干预措施: Standard Analgesia (Other)
结局指标
主要结局
Total postoperative opioid consumption
时间窗: First 24 hours after surgery
Cumulative morphine consumption (in mg morphine equivalents) delivered via patient-controlled analgesia (PCA) pump during the first 24 postoperative hours
次要结局
- Pain Intensity(Time in minutes from end of surgery until first request for rescue analgesia Time Frame: From end of surgery up to 72 hours)
- Duration of Sensory Block(From block performance up to 72 hours)
- Time to First Rescue Analgesia(From end of surgery up to 24 hours)
- Incidence of PONV(First 24 hours postoperatively)
- Length of hospital stay(From admission to discharge, assessed up to 30 days)
研究者
Nicolás Valls
Anesthesiologyst, Anesthesiology Department, Clínica Universidad de Los Andes
Universidad de los Andes, Chile