Does the use of a lower lumbar interspace for spinal anesthesia affect the efficacy of the block and maternal satisfaction?
| ISRCTN | ISRCTN27186410 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27186410 |
| Secondary identifying numbers | N0047129269 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 01/05/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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 Philip Moore
Scientific
Scientific
Anaesthetic Department: Labour Ward
Birmingham Women's Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Does the use of a lower lumbar interspace for spinal anesthesia affect the efficacy of the block and maternal satisfaction? |
| Study objectives | To find out whether spinal anaesthesia at the perceived L4-5 interspace is just as efficacious as that performed at the usual perceived L3-4 interspace, both clinically and for maternal satisfaction. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth: Anaesthesia |
| Intervention | Each volunteer will undergo normal clinical practice with the exception of random allocation to either the L3-4 or L4-5 interspace for insertion of spinal anesthetic. They will also be required to fill out a satisfaction questionnaire the day after delivery. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | That spinal anaesthesia at the perceived L45 interspace is just as efficacious as that performed at the perceived L3-4 interspace, both clinically and for maternal satisfaction. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 30/06/2003 |
| Completion date | 30/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 60 |
| Key inclusion criteria | 60 volunteers. All of whom will be having an elective caesarean under spinal anaesthesia and do not have any significant medical problems. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/06/2003 |
| Date of final enrolment | 30/07/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Birmingham Women's Hospital
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Birmingham Women's Healthcare NHS Trust (UK)
No information available
Results and Publications
| 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 |
