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Minimum Effective Dose (MED) & Epidural Bupivacaine

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02116842
Enrollment
100
Registered
2014-04-17
Start date
2012-12-31
Completion date
2014-05-31
Last updated
2014-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural Block, Labour, Pregnancy, Primigravida Labour

Brief 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.

Interventions

DRUG0.1% bupivacaine

Epidural block in early labour.

DRUG0.075% bupivacaine

Epidural block in early labour.

DRUG40 µg fentanyl

Given with different doses of bupivacaine in epidural block.

Sponsors

National Institute of Academic Anaesthesia (NIAA), UK
CollaboratorUNKNOWN
Obstetric Anaesthetists' Association United Kingdom
CollaboratorOTHER
University of Leeds
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effective dose in 95% of patients (ED95) dose of bupivacaine for a primigravida in early labour.up to 30 minutesTo find out the ED95 dose of bupivacaine 0.075% and 0.1% for epidural analgesia for a primigravida in early labour .

Countries

United Kingdom

Contacts

Primary ContactNeville Young
neville.young@leedsth.nhs.uk44 113 392 6459
Backup ContactLeeds Sponsor Office Quality Assurance Department
r&d@leedsth.nhs.uk44 113 392 2878

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026