PregnancyPhase 4NCT02116842
Minimum Effective Dose (MED) & Epidural Bupivacaine
A Phase 4 study testing 0.1% bupivacaine, 0.075% bupivacaine and 40 µg fentanyl in people with Pregnancy and Labour, run by University of Leeds at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy, Labour, Primigravida Labour
- What is being tested?
- 0.1% bupivacaine, 0.075% bupivacaine and 40 µg fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anaesthesiologists (ASA) 1-3 patients
- Primigravida (1st pregnancy) patients requesting epidural analgesia in early labour (≤ 5 cm cervical dilatation.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS9 7TF
Dr Sandeep Varma
About this study
Official title: 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.
Read more
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.
- Conditions
- Pregnancy, Labour, Primigravida Labour, Epidural Block
- Being tested
- 0.1% bupivacaine, 0.075% bupivacaine, 40 µg fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1% bupivacaineDrug
Epidural block in early labour.
0.075% bupivacaineDrug
Epidural block in early labour.
40 µg fentanylDrug
Given with different doses of bupivacaine in epidural block.
| Study group | Role | What they receive |
|---|---|---|
| 0.075% bupivacaine | Experimental | Consenting patients randomised to receive 0.075% bupivacaine and 40 µg fentanyl. Receives: Drug: 0.075% bupivacaine; Drug: 40 µg fentanyl |
| 0.1% bupivacaine | Experimental | Consenting patients randomised to receive 0.1% bupivacaine and 40 µg fentanyl. Receives: Drug: 0.1% bupivacaine; Drug: 40 µg fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startDec 2012
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Academic Anaesthesia (NIAA), UK, Obstetric Anaesthetists' Association United Kingdom
- Responsible party
- Principal investigator, Neville Young, University of Leeds
- Investigators
- Professor Philip M Hopkins, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116842
- Sponsor's protocol ID
- AN10/9307
- Other IDs
- 2010-020020-21, 11730
- Status last verified
- Apr 2014
- First submitted
- 15 Apr 2014
- Last updated
- 17 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the ED95 Dose of 0.075% and 0.1% Bupivacaine for Labour Analgesia in Primigravida.
- ClinicalTrials.gov ID
- NCT02116842
- Acronym / sponsor ID
- AN10/9307
- Conditions
- Pregnancy, Labour, Primigravida Labour, Epidural Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- National Institute of Academic Anaesthesia (NIAA), UK, Obstetric Anaesthetists' Association United Kingdom
- Study start
- Dec 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.075% bupivacaine | Experimental | Drug: 0.075% bupivacaine, Drug: 40 µg fentanylConsenting patients randomised to receive 0.075% bupivacaine and 40 µg fentanyl. |
| 0.1% bupivacaine | Experimental | Drug: 0.1% bupivacaine, Drug: 40 µg fentanylConsenting patients randomised to receive 0.1% bupivacaine and 40 µg fentanyl. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anaesthesiologists (ASA) 1-3 patients
- Primigravida (1st pregnancy) patients requesting epidural analgesia in early labour (≤ 5 cm cervical dilatation.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.1% bupivacaineEpidural block in early labour. | Drug | 0.1% bupivacaine |
| 0.075% bupivacaineEpidural block in early labour. | Drug | 0.075% bupivacaine |
| 40 µg fentanylGiven with different doses of bupivacaine in epidural block. | Drug | 0.075% bupivacaine, 0.1% bupivacaine |
Primary outcome
Effective dose in 95% of patients (ED95) dose of bupivacaine for a primigravida in early labour.
Time frame: up to 30 minutes
To find out the ED95 dose of bupivacaine 0.075% and 0.1% for epidural analgesia for a primigravida in early labour .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2014.
Related trials for Pregnancy
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
Not yet recruitingObservational study
Assessment of Intelligent Algorithms for Detection, Diagnosis and Risk Stratification of Tumors of the Kidney and Prostate
Kidney Cancers, Prostate Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
Active, not recruitingPhase 3
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7
Active, not recruitingPhase 1/2
AB-2100, an Integrated Circuit T Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC)
Advanced/Metastatic Clear Cell Renal Cell Carcinoma, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Philip M Hopkins principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.1% bupivacaine, 0.075% bupivacaine and 40 µg fentanyl in people with Pregnancy and Labour, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neville Young (44 113 392 6459, neville.young@leedsth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective dose in 95% of patients (ED95) dose of bupivacaine for a primigravida in early labour. (time frame: up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2014.