EFFICACY OF VASOCONSTRICTOR PERIARTICULAR INFILTRATION (PIV) VERSUS ERECTOR SPINAE PLANE BLOCK (ESP) IN REDUCING BLEEDING AND POSTOPERATIVE PAIN CONTROL IN LUMBAR ARTHRODESIS SURGERY. RANDOMIZED CLINICAL TRIAL.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- The primary variable will be intraoperative bleeding in the two study groups, calculated based on the suctioned fluids from the surgical field and the gauzes after extracting the irrigation fluids. Bleeding will be measured in milliliters (ml). The research team will collect the data from the anesthesia record of the procedure.
研究概览
简要总结
To compare the effectiveness of PIV block versus ESP block in reducing bleeding and improving postoperative pain control in lumbar fusion surgery, a procedure associated with significant blood loss and severe postoperative pain.
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomization
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Men and women scheduled for lumbar fusion surgery (maximum of 3 instrumented levels).
- •Age >18 years.
- •Signed informed consent form
排除标准
- •Allergy to local anesthetics.
- •Revision lumbar spine surgery.
- •Patients with a local infection.
- •Patients with connective tissue diseases or vasculitis.
- •Chronic pain treated with opioids (Oral Morphine Equivalent Dose > 50 mg/day).
结局指标
主要结局
The primary variable will be intraoperative bleeding in the two study groups, calculated based on the suctioned fluids from the surgical field and the gauzes after extracting the irrigation fluids. Bleeding will be measured in milliliters (ml). The research team will collect the data from the anesthesia record of the procedure.
The primary variable will be intraoperative bleeding in the two study groups, calculated based on the suctioned fluids from the surgical field and the gauzes after extracting the irrigation fluids. Bleeding will be measured in milliliters (ml). The research team will collect the data from the anesthesia record of the procedure.
次要结局
未报告次要终点
研究者
Alejandra Espinosa
Scientific
Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau