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
Protocol serial number	N0047129269
Sponsor	Department of Health
Funder	Birmingham Women's Healthcare NHS Trust (UK)

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

Dr Philip Moore
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/07/2004

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

Birmingham Women's Hospital

Birmingham
B15 2TH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan