Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
12/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maan Hasan

ORCID ID

Contact details

Department of Anaethetics Level 4J
Northwick Park Hospital
North West London Hospitals NHS Trust
Watford Road
Harrow
HA1 3UJ
United Kingdom
+44 (0)20 8869 3978

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes