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Patients planned to undergo elective lumbar spinal fusion surgery with a dorsal surgical approachTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
相关药物Ropivacaine HCl
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Patients planned to undergo elective lumbar spinal fusion surgery with a dorsal surgical approach
- 发起方
- Sint Maartenskliniek
- 入组人数
- 76
- 状态
- 进行中(未招募)
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
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
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;
结局指标
主要结局
未指定
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