Evaluation of a new device (patent publication GB 2366729) for identification of the epidural space

ISRCTN	ISRCTN08382589
DOI	https://doi.org/10.1186/ISRCTN08382589
Secondary identifying numbers	N0515163806

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Maan Hasan
Scientific

Department of Anaethetics Level 4J
Northwick Park Hospital
North West London Hospitals NHS Trust
Watford Road
Harrow
HA1 3UJ
United Kingdom

Phone	+44 (0)20 8869 3978

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Anaesthesia
Intervention	Randomised Controlled Trial
Intervention type	Device
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)
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 study start date	01/12/2002
Completion date	30/10/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	400
Key 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
Key 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
Date of first enrolment	01/12/2002
Date of final enrolment	30/10/2007

Department of Anaethetics Level 4J

Harrow
HA1 3UJ
United Kingdom

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

North West London Hospitals NHS Trust

No information available

NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan