Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2012-12-31
2014-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial of Onset of Epidural Pain Relief With Low Dose Bupivacaine and Different Doses of Fentanyl in Laboring Women
NCT02004899
Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections
NCT01558713
Subarachnoid Administration of Levobupivacaine for Cesarean Section
NCT01582607
Bupivacaine, Levobupivacaine and Ropivacaine After Intrathecal and Extradural Injection in Labour
NCT01201213
Dosing Strategies for Automated Mandatory Intermittent Boluses Technique for Epidural Labour Analgesia
NCT01205360
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
0.075% bupivacaine
Consenting patients randomised to receive 0.075% bupivacaine and 40 µg fentanyl.
0.075% bupivacaine
Epidural block in early labour.
40 µg fentanyl
Given with different doses of bupivacaine in epidural block.
0.1% bupivacaine
Consenting patients randomised to receive 0.1% bupivacaine and 40 µg fentanyl.
0.1% bupivacaine
Epidural block in early labour.
40 µg fentanyl
Given with different doses of bupivacaine in epidural block.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Primigravida (1st pregnancy) patients requesting epidural analgesia in early labour (≤ 5 cm cervical dilatation.
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Academic Anaesthesia (NIAA), UK
UNKNOWN
Obstetric Anaesthetists' Association United Kingdom
OTHER
University of Leeds
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Neville Young
Sponsor Quality Assurance Manager
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Professor Philip M Hopkins
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-020020-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11730
Identifier Type: OTHER
Identifier Source: secondary_id
AN10/9307
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.