Localization of the Epidural Space Using the Loss of Resistance Technique for Labour Analgesia: A Randomized Controlled Trial Comparing Air Versus Saline Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 主要终点
- Analgesia obtained 30 minutes after the puncture of the epidural block (variation of pain score)
研究概览
简要总结
Epidural space localization using loss of resistance technique with air (ALOR) is controversial in obstetric analgesia due to a minor efficacy and risk of complications, compared with loss of resistance technique with saline (SLOR). This randomized prospective study will compare the efficacy and incidence of most common complications of both techniques in obstetric analgesia.
详细描述
A local ethics committee has approved the study. A statistical power calculation was performed and 177 patients per group will be necessary to confirm a 20% difference of efficacy of the block at 30 minutes (α=0,05; β=0,1). Epidural catheter will be inserted and a standardized analgesic protocol will initiate. The efficacy of the block will be assessed after 30 minutes and at delivery. The apparition of adverse effects during puncture and labour will be annotated. The need for repuncture of the block and the repercussion of the technique on the delivery and the fetus will be recorded as well. At 24 hours, investigators will assess the incidence of pain at the site of puncture (PSP) and the level of maternal satisfaction on a 0 to10 numeric scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Parturients asking for epidural analgesia during labour .
- •Age between 18 and 45 years.
- •Spontaneous or induced.
- •Cervical dilatation inferior to 6 cm.
- •Written informed consent.
排除标准
- •Infection in the puncture site.
- •Refusal of the patient.
- •Coagulopathy.
- •Severe hypovolaemia.
- •Intracranial hypertension.
- •Severe aortic or mitral stenosis.
- •Systemic infection.
- •Non collaborating patient.
- •Incapacity of communicating or lack of comprehension of the study by the parturient
- •Prior neurological symptoms or demyelinising lesions.
- •Valvular stenosis.
- •Severe spinal deviation.
- •Patient previously operated of spinal surgery in the site of puncture.
研究组 & 干预措施
air in epidural space
When the ALOR epidural localization technique will be used, an intermittent pressure with fast movements will be exerted on the plunger of the syringe while the Tuohy needle will be inserted until loss of resistance was felt.
干预措施: air in epidural space (Procedure)
saline in epidural space
When the SLOR technique is used, a continuous pressure will be exerted on the plunger of the Tuohy needle until loss of resistance was felt.
干预措施: saline in epidural space (Procedure)
结局指标
主要结局
Analgesia obtained 30 minutes after the puncture of the epidural block (variation of pain score)
时间窗: 30 min
次要结局
未报告次要终点