Minimum Effective Dose (MED) & Epidural Bupivacaine

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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy; Labour; Epidural Block; Primigravida Labour
• Intervention / Treatment: Drug: 0.075% bupivacaine; Drug: 40 µg fentanyl; Drug: 0.1% bupivacaine

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Neville Young; Phone Number: 44 113 392 6459; Email: neville.young@leedsth.nhs.uk
• Study Contact Backup: Name: Leeds Sponsor Office Quality Assurance Department; Phone Number: 44 113 392 2878; Email: r&d@leedsth.nhs.uk

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Recruiting
      • Leeds Teaching Hospitals NHS Trust
      • Principal Investigator: Dr Sandeep Varma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.075% bupivacaine; Consenting patients randomised to receive 0.075% bupivacaine and 40 µg fentanyl.	Drug: 0.075% bupivacaine; Epidural block in early labour.; Drug: 40 µg fentanyl; Given with different doses of bupivacaine in epidural block.
Experimental: 0.1% bupivacaine; Consenting patients randomised to receive 0.1% bupivacaine and 40 µg fentanyl.	Drug: 40 µg fentanyl; Given with different doses of bupivacaine in epidural block.; Drug: 0.1% bupivacaine; Epidural block in early labour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: National Institute of Academic Anaesthesia (NIAA), UK; Obstetric Anaethetists' Association (OAA), UK
• Investigators: Principal Investigator: Professor Philip M Hopkins, University of Leeds

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 16, 2014
• First Posted (Estimate): April 17, 2014

Study Record Updates

• Last Update Posted (Estimate): April 17, 2014
• Last Update Submitted That Met QC Criteria: April 16, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: AN10/9307; 11730 (Other Identifier: UKCRN); 2010-020020-21 (EudraCT Number)