Condition category
Pregnancy and Childbirth
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
01/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philip Moore

ORCID ID

Contact details

Anaesthetic Department: Labour Ward
Birmingham Women's Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0047129269

Study information

Scientific title

Does the use of a lower lumbar interspace for spinal anesthesia affect the efficacy of the block and maternal satisfaction?

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

30/06/2003

Overall trial end date

30/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

60 volunteers. All of whom will be having an elective caesarean under spinal anaesthesia and do not have any significant medical problems.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

30/06/2003

Recruitment end date

30/07/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Birmingham Women's Hospital
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Birmingham Women's Healthcare NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes