Does Preprocedural Ultrasound Exam of Lumbar Spine Increase the First-pass Success Rate of Epidural Space Identification Among Obese Parturients: A Randomized Controlled Open Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Success of the epidural space identification at the first needle pass
研究概览
简要总结
Obesity is associated with difficulties in epidural space catheterization. The investigators want to prove that a pre-procedural ultrasound exam of lumbar spine increase the first-pass success rate of the epidural space identification among obese parturients.
详细描述
This study was a randomized controlled open trial with two parallel groups.
Study was conducted in only one center : the maternity of University Hospital of Caen (Normandy, France)
Written informed consent was obtained from eligible subjects after the pre-anesthetic interview in the 8th month of pregnancy.
Operators were medical interns or residents in anesthesiology. Before inclusion, they all spent an individual interview in the aim to practice ultrasound exam of lumbar spine.
Eligible subjects were full-term parturients with pre-pregnancy BMI ≥ 30 kg/m2 undergoing vaginal delivery and receiving epidural labor analgesia. Exclusion criteria were usual contraindications for neuraxial anesthesia, marked spinal deformity, previous spinal surgery and emergency context.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Full-term parturients (≥ 37 weeks of amenorrhea)
- •With pre-pregnancy BMI ≥ 30 kg/m2
- •Admit for a vaginal delivery
- •Receiving labour epidural analgesia
排除标准
- •Usual contraindications for neuraxial anesthesia (thrombocytopenia, coagulopathy, uncorrected hypovolemia, infected puncture site, intracranial hypertension)
- •Emergency maternal and foetal cases
- •Twin pregnancy
- •Marked spinal deformity ou previous spinal surgery
- •Refusal to participate
结局指标
主要结局
Success of the epidural space identification at the first needle pass
时间窗: Baseline up to 1 hour
Succes rate of the epidural space identification at the first needle pass (first skin puncture and without needle redirection) for each group
次要结局
- Number of needle redirections(Baseline up to 1 hour)
- Number of intervertebral space punctured(Baseline up to 1 hour)
- Number of skin punctures(Baseline up to 1 hour)
- Duration of the epidural procedure(Baseline up to 1 hour)
- Success of the epidural space identification at the first skin puncture(Baseline up to 1 hour)
- Accidental Dural puncture(Baseline up to 1 hour)
- Post dural puncture headache(48 hours after the epidural procedure)
- Early Failed of the epidural analgesia(30 minutes after the end of the procedure)
- Verbal Rating Scale(30 minutes and 120 minutes after the epidural procedure)
- Quality of epidural analgesia(48 hours after the epidural procedure)
- Maternal perception of the duration of the epidural procedure(48 hours after the epidural procedure)