Minimum Effective Dose (MED) & Epidural Bupivacaine | NCT02116842

Studies
Minimum Effective Dose (MED) & Epidural Bupivacaine

NCT02116842

Sponsor

University of Leeds

Status

Unknown status

Last Update Posted

Apr 17, 2014Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Pregnancy
Labour
Primigravida Labour
Epidural Block

Interventions

0.1% bupivacaine
0.075% bupivacaine
40 µg fentanyl

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-020020-21	EudraCT Number
11730	Other Identifier	UKCRN

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

May 2014Estimated

Completion Date

May 2014Estimated

First Submitted Date

Apr 15, 2014

First Submission Date that Met QC Criteria

Apr 16, 2014

First Posted Date

Apr 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2014

Last Update Posted Date

Apr 17, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Neville Young, Sponsor Quality Assurance Manager, University of LeedsPrincipal Investigator

Lead Sponsor

University of LeedsOTHER

Collaborators

Name	Class
National Institute of Academic Anaesthesia (NIAA), UK	UNKNOWN
Obstetric Anaesthetists' Association United Kingdom	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.075% bupivacaine	Experimental	Consenting patients randomised to receive 0.075% bupivacaine and 40 µg fentanyl.	Drug: 0.075% bupivacaine Drug: 40 µg fentanyl
0.1% bupivacaine	Experimental	Consenting patients randomised to receive 0.1% bupivacaine and 40 µg fentanyl.	Drug: 0.1% bupivacaine Drug: 40 µg fentanyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.1% bupivacaine	Drug	Epidural block in early labour.	0.1% bupivacaine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Neville Young	Contact	44 113 392 6459		neville.young@leedsth.nhs.uk
Leeds Sponsor Office Quality Assurance Department	Contact	44 113 392 2878		r&d@leedsth.nhs.uk

Overall Officials

Name	Affiliation	Role
Professor Philip M Hopkins	University of Leeds	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leeds Teaching Hospitals NHS Trust	Recruiting	Leeds	West Yorkshire	LS9 7TF	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D005283	Fentanyl

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

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Browse Branches

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