NCT02116842

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_4 pregnancy

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 17, 2014

Status Verified

April 1, 2014

Enrollment Period

1.4 years

First QC Date

April 15, 2014

Last Update Submit

April 16, 2014

Conditions

PregnancyLabourPrimigravida LabourEpidural Block

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

0.075% bupivacaine

EXPERIMENTAL

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

Drug: 0.075% bupivacaineDrug: 40 µg fentanyl

0.1% bupivacaine

EXPERIMENTAL

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

Drug: 0.1% bupivacaineDrug: 40 µg fentanyl

Interventions

0.1% bupivacaineDRUG

Epidural block in early labour.

0.1% bupivacaine
0.075% bupivacaineDRUG

Epidural block in early labour.

0.075% bupivacaine
40 µg fentanylDRUG

Given with different doses of bupivacaine in epidural block.

0.075% bupivacaine0.1% bupivacaine

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anaesthesiologists (ASA) 1-3 patients
  • Primigravida (1st pregnancy) patients requesting epidural analgesia in early labour (≤ 5 cm cervical dilatation.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Interventions

BupivacaineFentanyl

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Professor Philip M Hopkins

    University of Leeds

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neville Young

CONTACT

44 113 392 6459neville.young@leedsth.nhs.uk

Leeds Sponsor Office Quality Assurance Department

CONTACT

44 113 392 2878r&d@leedsth.nhs.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sponsor Quality Assurance Manager

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 17, 2014

Study Start

December 1, 2012

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

April 17, 2014

Record last verified: 2014-04

Locations

GB(1)