NCT07228039尚未招募4 期
A Double-Blind Prospective RCT Assessment of ESP Blocks for Analgesia Following Posterior Spinal Fusion
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Postoperative Pain as measured by opiate consumption
研究概览
简要总结
This prospective randomized double-blind study evaluates the efficacy of erector spinae plane (ESP) blocks on postoperative pain in patients undergoing cervical or lumbar posterior spinal fusion. Patients will receive either 0.5% bupivacaine plus liposomal bupivacaine or 0.5% plain bupivacaine. Outcomes include opioid consumption over 72 hours, pain scores, length of stay, and time to ambulation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Age 18-75
- •ASA physical status 1-3
- •Undergoing elective cervical or lumbar posterior spinal fusion (≤3 levels)
排除标准
- •Age <18 or >75
- •ASA IV or V
- •Non-English speaking
- •Opioid dependence
- •Chronic pain
- •Anticoagulation or coagulopathy
- •Injection site infection
- •Hepatic or renal insufficiency
- •Allergy to study drugs
- •Pregnancy
- •Inability to communicate with investigators
研究组 & 干预措施
ESP + Plain Bupivacaine
Experimental
Group 2 receives ESP block with 0.5% plain bupivacaine.
干预措施: ESP Block with Bupivacaine (Drug)
ESP + Liposomal Bupivacaine
Experimental
Group 1 receives ESP block with 0.5% bupivacaine plus liposomal bupivacaine.
干预措施: ESP Block with Bupivacaine + Liposomal Bupivacaine (Drug)
结局指标
主要结局
Postoperative Pain as measured by opiate consumption
时间窗: 72 hours
Morphine MilliEquivalents
次要结局
- Postoperative Pain at rest and with movement as measured by patient reported pain scores(4, 8, 12, 24, 48, and 72 hours)
- Discharge Readiness(72 hours)
- Postoperative Pain Severity as measured by required time for patient controlled-analgesia(72 hours)
- Incidents of post-operative nausea and vomiting(72 hours)
- Time to first ambulation(72 hours)
研究者
研究点 (2)
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