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MED and Epidural Bupivacaine

Comparison of the ED95 dose of 0.075% and 0.1% bupivacaine for labour analgesia in primigravida

Specialty
Anaesthesia (co-adopted by ReproductiveHealth)
Portfolio Eligibility
Automatically eligible
ISRCTN
EudraCT
MREC N°
UKCRN ID 11730
WHO ID
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.
Study Type Interventional
Design Type Treatment
Disease(s) Reproductive Health & Childbirth
All Anaesthesia, perioperative medicine and pain management
Phase N/A
Current Status In Set-Up NHS Permission Received
Closure Date 3/1/2013
Global Sample Size 100
Geographical Scope Single Centre
Lead Country England
Open to new sites No
Main Inclusion Criteria
ASA 1-3 patients
Age > 18 years
Primigravida (1st pregnancy) patients requesting epidural analgesia in early labour (≤ 5 cm cervical dilatation)
Main Exclusion Criteria
Primigravida (1st pregnancy) patients requesting epidural analgesia in late labour (> 5 cm cervical dilatation)
Multigravida patients ( ≥ 2nd pregnancy)
ASA > 3
Age < 18 years
Allergy to Bupivacaine
Unable to give written informed consent
BMI >35
Abnormal blood coagulation profile
Patients taking any medication that are indicated in the SPC as not recommended
Chief Investigator(s)
Prof Phil Hopkins
Further details, please contact
Prof Phil Hopkins

St. James's University Hospital

Beckett Street
Leeds
West Yorkshire
LS9 7TF
UNITED KINGDOM

p.m.hopkins@leeds.ac.uk
Funder(s) Obstetrics Anaesthetists' Association (OAA)
Sponsor(s)




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