EUCTR2021-003679-32-NL进行中（未招募）1 期
Erector spinae plane block for reduction of early postoperative pain scores and opioid use in lumbar spinal fusion surgery, a prospective double-blinded randomized placebo controlled trial - RCT-ESPB
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •- Age = 18 years;
- •- Patients planned for elective lumbar spinal fusion surgery with a dorsal surgical approach;
- •- 2-4 level spine fusion surgery;
- •- Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •A Body Mass Index (BMI) > 40 kg/m²;
- •ASA physical health classification > 3;
- •Patients who will undergo spine surgery involving less than 2 or more than 4 levels of fusion, scoliosis surgery;
- •Patients who will undergo circumferent spine surgery;
- •Patients with an active, local infection or systemic infection;
- •Patients with an allergy to one or more medications used in the study;
- •Patients with any contraindication to a regional anesthetic technique;
- •Kidney- or liver failure inhibiting the systemic use of paracetamol and/or NSAIDs;
- •Acute surgeries;
- •Patients with a history of drugs or alcohol abuse;
- •Pregnancy;
- •Cognitive impairment.
研究者
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