Minimum Effective Dose (MED) & Epidural Bupivacaine

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.

Conditions

• Pregnancy
• Labour
• Primigravida Labour
• Epidural Block

Interventions

DRUG

0.1% bupivacaine

Epidural block in early labour.

DRUG

0.075% bupivacaine

Epidural block in early labour.

DRUG

40 µg fentanyl

Given with different doses of bupivacaine in epidural block.

Sponsors & Collaborators

• National Institute of Academic Anaesthesia (NIAA), UK

  collaborator UNKNOWN

• Obstetric Anaesthetists' Association United Kingdom

  collaborator OTHER

• University of Leeds

  lead OTHER

Principal Investigators

• Professor Philip M Hopkins · University of Leeds

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2014-05-31

Completion

2014-05-31

Countries

• United Kingdom

Study Locations