Minimum Effective Dose (MED) & Epidural Bupivacaine
Information source: University of Leeds
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pregnancy; Labour; Primigravida Labour; Epidural Block
Intervention: 0.1% bupivacaine (Drug); 0.075% bupivacaine (Drug); 40 µg fentanyl (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Leeds Official(s) and/or principal investigator(s):
Professor Philip M Hopkins, Principal Investigator, Affiliation: University of Leeds
Overall contact:
Neville Young, Phone: 44 113 392 6459, Email: neville.young@leedsth.nhs.uk
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.
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.
Clinical Details
Official title: Comparison of the ED95 Dose of 0.075% and 0.1% Bupivacaine for Labour Analgesia in Primigravida.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Effective dose in 95% of patients (ED95) dose of bupivacaine for a primigravida in early labour.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- American Society of Anaesthesiologists (ASA) 1-3 patients
- Primigravida (1st pregnancy) patients requesting epidural analgesia in early labour
(≤ 5 cm cervical dilatation.
Exclusion Criteria:
- Primigravida (1st pregnancy) patients requesting epidural analgesia in late labour (>
5 cm cervical dilatation)
- Multigravida patients ( ≥ 2nd pregnancy)
- ASA > 3
- Allergy to Bupivacaine
- Unable to give written informed consent
- BMI >35
- Abnormal blood coagulation profile
- Patients taking any medication that are indicated in the Summary of Product
Characteristics (SPC) as not recommended
Locations and Contacts
Neville Young, Phone: 44 113 392 6459, Email: neville.young@leedsth.nhs.uk
Leeds Teaching Hospitals NHS Trust, Leeds, West Yorkshire LS9 7TF, United Kingdom; Recruiting
Dr Sandeep Varma, Principal Investigator
Additional Information
Starting date: December 2012
Last updated: April 16, 2014
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