MED and Epidural Bupivacaine
Research type
Research Study
Full title
Comparison of the ED95 dose of 0.075% and 0.1% bupivacaine for labour analgesia in primigravida
IRAS ID
50545
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Eudract number
2010-020020-21
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
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.Till 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% patient)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.We are aiming to complete this trial within one year.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
11/YH/0024
Date of REC Opinion
12 Jul 2011
REC opinion
Further Information Favourable Opinion