Effect of Erector Spinae Plane Block on Postoperative Nausea and Vomiting in Lumbar Disc Herniation Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- PONV
研究概览
简要总结
This study will investigate the hypothesis that preoperative erector spinae plane (ESP) block will reduce the incidence of postoperative nausea and vomiting (PONV) in patients undergoing elective lumbar disc herniation (LDH) surgery. PONV was defined as the presence of nausea and vomiting within 24 hours postoperatively.
详细描述
The study will include patients aged 18 years and older, with (American Society of Anesthesiologists) ASA physical status I and II, and scheduled for single-level lumbar disc herniation surgery under general anesthesia. Patient characteristics (age, gender, body mass index, etc.), Apfel score, postoperative nausea and vomiting (PONV) status, intraoperative opioid use requirement, surgical duration, postoperative pain status, rescue analgesic and emetic requirement will be recorded. The primary outcome parameter will be the PONV incidence within the postoperative 24 hours. PONV severity during this period will be assessed using a Likert scale from 0 to 10. PONV will be defined as vomiting, marked nausea (numerical rating scale [NRS] ≥4), and/or need for rescue medication. Patients will be assessed for PONV at 0, 2, 4, 12, and 24 hours using the Likert scale. Nausea and its severity, vomiting attacks, need for intraoperative opioid use, pain and its severity, need for additional analgesics, and administration of antiemetic rescue medication will be evaluated as secondary outcome parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and above
- •ASA physical status I to II
- •One lumbar disc herniation surgery under general anesthesia
排除标准
- •body mass index >35 kg/m²)
- •history of drug use
- •nausea and vomiting before surgery
- •psychiatric disorders
- •use of antipsychotic or antiemetic drugs
- •severe heart disease
- •central nervous system diseases
- •vertebrobasilar artery insufficiency
- •cytostatic therapy
- •vestibular diseases
- •renal and/or hepatic dysfunction
- •pregnant patients
- •presence of bleeding diathesis
- •patients in a condition where cooperation cannot be established in the post-operative period (mental retardation etc.)
- •patient's refusal to accept the block procedure
- •allergy to local anesthetics
- •injection site infection
研究组 & 干预措施
Erector spinae plane (ESP) block
Patients will receive an erector spinae plane (ESP) block in addition to standard medical treatment to prevent PONV and postoperative pain.
干预措施: ESP (Other)
No Erector spinae plane (ESP) block
Patients will receive standard medical treatment to prevent PONV and postoperative pain.
干预措施: No ESP (Other)
结局指标
主要结局
PONV
时间窗: 24 hours
The primary outcome of the study was the incidence of postoperative nausea and/or vomiting
次要结局
- Severity of nausea(24 hours)
- 11 - point numerical rating scale (NRS)(24 hours)
- Rescue antiemetic requirement(24 hours)
- Rescue analgesic requirement(24 hours)
- intraoperative opioid requirement(intraoperative time)
研究者
Gökhan Erdem
Anesthesiology and Reanimation specialist doctor
Ankara City Hospital Bilkent