Minimum Effective Dose (MED) & Epidural Bupivacaine

Pregnancy Clinical Trial

Official title:

Comparison of the ED95 Dose of 0.075% and 0.1% Bupivacaine for Labour Analgesia in Primigravida.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02116842
• Other study ID #: AN10/9307
• Secondary ID: 2010-020020-2111
• Status: Recruiting
• Phase: Phase 4
• First received: April 15, 2014
• Last updated: April 16, 2014
• Start date: December 2012
• Est. completion date: May 2014

Study information

• Verified date: April 2014
• Source: University of Leeds
• Contact: Neville Young
• Phone: 44 113 392 6459
• Email: neville.young[@]leedsth.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epidural Block
• Labour
• Pregnancy
• Primigravida Labour

Intervention

Drug:
• 0.1% bupivacaine
Epidural block in early labour.
• 0.075% bupivacaine
Epidural block in early labour.
• 40 µg fentanyl
Given with different doses of bupivacaine in epidural block.

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds	West Yorkshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Leeds	National Institute of Academic Anaesthesia (NIAA), UK, Obstetric Anaethetists' Association (OAA), UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective dose in 95% of patients (ED95) dose of bupivacaine for a primigravida in early labour.	To find out the ED95 dose of bupivacaine 0.075% and 0.1% for epidural analgesia for a primigravida in early labour .	up to 30 minutes	Yes