The Effect of the Body Temperature 0.75% Ropivacaine on the Time to Convert Labour Epidural Analgesia to Anaesthesia for Surgical Delivery
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time to onset of surgical anaesthesia - loss of sensation to cold at T4 bilaterally as assessed with ethyl-chloride spray.
研究概览
简要总结
The purpose of this study is to determine weather using warmed (body temperature) 0.75% Ropivicaine to convert labour epidural analgesia to surgical anaesthesia, reduces the onset time of surgical block, compared to standard room temperature
详细描述
In this prospective, randomised, controlled, double-blind study; parturients with functioning labour epidural analgesia requiring conversion to anaesthesia for surgical delivery (SD) - will be randomised into control and intervention groups: room temperature (RT) and body temperature (BT). The control group (RT) will receive room temperature Ropivacaine 0.75%, as is the standard practice. The treatment group (BT) will receive 0.75% Ropivicaine warmed up to 37°C temperature. Block height will be assessed every 2 minutes by a blinded investigator until the loss of sensation to cold at the level of T4, sensation to touch will be used as second modality.
Primary outcome is the time to loss of sensation to cold at T4 bilaterally as assessed with ethyl-chloride spray. Secondary outcomes will include motor block, haemodynamic stability, and use of vasopressors, shivering, sweating, nausea, pruritus, body temperature, intra-operative supplementation, and Apgar scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I-II women with an established labour epidural
- •Labour analgesia with standard low-dose mixture PCEA
- •Need for surgical delivery
排除标准
- •Category 1 (crash) CS
- •Spinal blockade, suggesting migration of epidural catheter
- •Use of epidural bupivacaine 0.25-0.5% within 1 h
- •Pyrexial parturian - ≥38°C temperature before administration of top-up
- •Multiply pregnancy
- •Eclampsia
- •An allergy or idiosyncratic reaction to local anaesthetic
- •Patient refusal
研究组 & 干预措施
room temperature - RT
Ropivacaine used for Epidural top-up administered at room temperature
干预措施: Ropivicaine (Drug)
body temperature BT
Ropivacaine used for Epidural top-up administered warmed to body temperature
干预措施: warming of ropivacaine for BT (Other)
body temperature BT
Ropivacaine used for Epidural top-up administered warmed to body temperature
干预措施: Ropivicaine (Drug)
结局指标
主要结局
Time to onset of surgical anaesthesia - loss of sensation to cold at T4 bilaterally as assessed with ethyl-chloride spray.
时间窗: up to 30 min
次要结局
- Adverse effects: itching, shivering, nausea, vomiting measured on a four-point scale (0=none, 1=mild, 2=moderate, 3=severe), drop of SBP >20% of the baseline and need for vasopressors during the surgery(intraoperative)
- Quality of block during surgery - incidence of repeated top-up, intravenous opioids, inhaled nitrous oxide, conversion to spinal or general anaesthesia(intraoperative)
- Intensity of motor block - Bromage scale 3(up to 30 min)