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

Completed

• Conditions: Anaesthesia; Surgery

• Registration Number: ISRCTN08382589
• Lead Sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 400

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.

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detailed in protocol and its supplements. Will be misleading to attempt to cover that in this small space.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration