Randomised, double-blind, controlled study of combined spinal epidural (CSE) analgesia for labour with and without epidural volume extension (EVE).
| ISRCTN | ISRCTN21230935 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21230935 |
| Protocol serial number | N0016127111 |
| Sponsor | Department of Health |
| Funder | Hammersmith Hospital NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 31/07/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Pregnancy and Childbirth
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
Contact information
Dr Gary Stocks
Scientific
Scientific
Department of Anaesthesia
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Whether using the CSE technique with EVE, can achieve the same quality of analgesia but with a quicker onset of action, and reduce the degree of unwanted motor block currently experienced in a proportion of patients. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth: Analgesia |
| Intervention | As of 29/07/09 the status of this trial was changed to 'stopped'. This trial was never commenced. Not provided at time of registration. |
| Intervention type | Other |
| Primary outcome measure(s) |
To improve our existing CSE labour analgesia, in terms of rapidity of onset of action and decreased motor block in the lower limbs allowing earlier ambulation. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2004 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/07/2003 |
| Date of final enrolment | 31/07/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Anaesthesia
London
W6 8RF
United Kingdom
W6 8RF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
