Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0515163806
Study information
Scientific title
Acronym
Study hypothesis
To evaluate a new device (patent publication GB2366729) for identification of the epidural space. In particular to test the claimed advantages:
1. Reducing failure rates for epidural insertions which are presently quoted in the literature at a range of 7-23% or an average of 15%
2. Reducing the number of attempts before achieving a successful epidural insertion
3. Reducing the insertion time
4. Ease of use scale
5. Steep or zero learning curve
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Anaesthesia
Intervention
Randomised Controlled Trial
Intervention type
Device
Phase
Not Specified
Drug names
Primary outcome measure
Detailed in protocol and its supplements. Will be misleading to attempt to cover that in this small space.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2002
Overall trial end date
30/10/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
We have estimated that 400 patients (200 Epidrums) will be required for this study. This was estimated for the required significance of difference at a p value of less than 0.05 and for the average failure rate quoted above, number of attempts at epidural needle insertion and ease of its use scale, and the expected differences in learning curves. We estimated that the power of this study with the number of patients above will not be enough for incidence of complication such PDPH, and neurological complications which will be tested later in larger multi-centre trials. Two hundred patients in each group, sixteen to eighty years.
Inclusion criteria:
1. Patients over 18 and under 80 years of age
2 Clinical need for epidural injection
3. Absence of any contraindication to epidural injection, relative or absolute
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
400
Participant exclusion criteria
1. Patients under 18 and over 80 years of age
2. Bleeding tendency, local infection, bacteraemia or septicaemia
3. Unable or unwilling to give consent
4. All other relative clinical contraindications to epidural injection or anaesthesia
Recruitment start date
01/12/2002
Recruitment end date
30/10/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaethetics Level 4J
Harrow
HA1 3UJ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
North West London Hospitals NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list