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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleDoes the use of a lower lumbar interspace for spinal anesthesia affect the efficacy of the block and maternal satisfaction?
Study objectivesTo 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) studiedPregnancy and Childbirth: Anaesthesia
InterventionEach 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureThat 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 measuresNot provided at time of registration
Overall study start date30/06/2003
Completion date30/07/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants60
Key inclusion criteria60 volunteers. All of whom will be having an elective caesarean under spinal anaesthesia and do not have any significant medical problems.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment30/06/2003
Date of final enrolment30/07/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Birmingham Women's Hospital
Birmingham
B15 2TH
United Kingdom

Sponsor information

Department of Health
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan