Pregnancy Clinical Trial
Official title:
Comparison of the ED95 Dose of 0.075% and 0.1% Bupivacaine for Labour Analgesia in Primigravida.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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