Minimum Effective Dose (MED) & Epidural Bupivacaine

University of Leeds

Status and phase: Unknown; Phase 4

Conditions: Epidural Block; Primigravida Labour; Labour; Pregnancy

Treatments: Drug: 0.1% bupivacaine; Drug: 40 µg fentanyl; Drug: 0.075% bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02116842

2010-020020-21 (EudraCT Number)

11730

AN10/9307

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

0.075% bupivacaine

Experimental group

Description:

Consenting patients randomised to receive 0.075% bupivacaine and 40 µg fentanyl.

Treatment:

Drug: 40 µg fentanyl

Drug: 0.075% bupivacaine

0.1% bupivacaine

Experimental group

Description:

Consenting patients randomised to receive 0.1% bupivacaine and 40 µg fentanyl.

Treatment:

Drug: 0.1% bupivacaine

Drug: 40 µg fentanyl