Comparison of the ED95 Dose of 0.075% and 0.1% Bupivacaine for Labour Analgesia in Primigravida.
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effective dose in 95% of patients (ED95) dose of bupivacaine for a primigravida in early labour.
研究概览
简要总结
Local anaesthetics are highly toxic drugs. They can cause toxicity by an absolute overdose, accidental injection in a blood vessel or slow absorption from the area of injection. The risk of toxicity when performing regional anaesthesia can be reduced significantly by injecting the optimal dose of local anaesthetic at the correct site.
To date most of the local anaesthetic dose finding studies for epidural labour analgesia has focused on ED50 ( the dose effective in 50% of patients). The purpose of this research study is to find out the ED95 dose (the dose effective in 95% of patients) of local anaesthetic for epidural analgesia in labour.
The dose determined from this research trial will guide the anaesthetists to the optimal starting dose of the local anaesthetics for epidural analgesia in labour. This would lead to decreased chances of toxicity and will improve patient safety.
We aim to recruit a total of 100 pregnant patients in early labour (cervical dilatation ≤ 5 cm) requesting epidural analgesia to answer the research question based on the continual reassessment method. Patients will be recruited according to well-defined criteria. They will be fully informed about the study and have the choice of not participating or opting out at any time during the study. It is not going to affect the kind of treatment they receive. The experts in the field with full safety precautions will perform this study at St James' Hospitals, Leeds.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anaesthesiologists (ASA) 1-3 patients
- •Primigravida (1st pregnancy) patients requesting epidural analgesia in early labour (≤ 5 cm cervical dilatation.
排除标准
- •Primigravida (1st pregnancy) patients requesting epidural analgesia in late labour (> 5 cm cervical dilatation)
- •Multigravida patients ( ≥ 2nd pregnancy)
- •Allergy to Bupivacaine
- •Unable to give written informed consent
- •Abnormal blood coagulation profile
- •Patients taking any medication that are indicated in the Summary of Product Characteristics (SPC) as not recommended
研究组 & 干预措施
0.075% bupivacaine
Consenting patients randomised to receive 0.075% bupivacaine and 40 µg fentanyl.
干预措施: 0.075% bupivacaine (Drug)
0.075% bupivacaine
Consenting patients randomised to receive 0.075% bupivacaine and 40 µg fentanyl.
干预措施: 40 µg fentanyl (Drug)
0.1% bupivacaine
Consenting patients randomised to receive 0.1% bupivacaine and 40 µg fentanyl.
干预措施: 0.1% bupivacaine (Drug)
0.1% bupivacaine
Consenting patients randomised to receive 0.1% bupivacaine and 40 µg fentanyl.
干预措施: 40 µg fentanyl (Drug)
结局指标
主要结局
Effective dose in 95% of patients (ED95) dose of bupivacaine for a primigravida in early labour.
时间窗: up to 30 minutes
To find out the ED95 dose of bupivacaine 0.075% and 0.1% for epidural analgesia for a primigravida in early labour .
次要结局
未报告次要终点
研究者
Neville Young
Sponsor Quality Assurance Manager
University of Leeds