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 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 trial start date
30/06/2003
Overall trial end date
30/07/2004
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list