Anaesthesia Surgery Anaesthesia
Conditions
Interventions
Randomised Controlled Trial
Sponsors
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detailed in protocol and its supplements. Will be misleading to attempt to cover that in this small space. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed