Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R&D/2007/08
Study information
Scientific title
Randomised controlled trial to assess the difference of spinal anaesthesia versus general anaesthesia in hip replacement surgery
Acronym
Study hypothesis
Spinal anaesthesia is as good as general anaesthesia in hip replacement surgery.
Ethics approval
Hertfordshire 2 Research Ethics Committee, 05/02/2007, ref: 06/Q0204/137
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
Hip fracture
Intervention
Intervention 1: Spinal anaesthesia with injection of 2 ml 0.5% bupivicaine
Intervention 2: General anaesthesia: femoral nerve block using 30 ml of 0.25% bupivicaine, induction with propofal and fentanyl 1 mcg/kg and maintenance with nitrous oxide/oxygen and isoflurothane
Follow up will be for the duration of the hip replacement surgery until fully conscious and for the subsequent in patient hospitalisation. Subsequent follow up will be at six weeks and one year.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Pain will be assessed by asking open questions and performing an assessment of the amount of analgesia required.
Secondary outcome measures
1. Mobility will be assessed by using a specially designed questionnaire
2. Confusion will be assessed by using the Mini Mental Questionnaire
Overall trial start date
01/04/2007
Overall trial end date
31/12/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Acute hip replacement surgery
2. Aged greater than 49
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant exclusion criteria
1. Conservative treatment for hip fracture
2. Unsuitable for spinal or general anaesthesia
Recruitment start date
01/04/2007
Recruitment end date
31/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Peterborough and Stamford Hospitals Foundation NHS Trust
Peterborough
PE3 6DA
United Kingdom
Sponsor information
Organisation
Peterborough and Stamford Hospitals NHS Foundation Trust (UK)
Sponsor details
Thorpe Road
Peterborough
PE3 6DA
United Kingdom
Sponsor type
Government
Website
http://www.peterboroughhospitals.co.uk/page_viewer.asp?category=Home&sid=8
Funders
Funder type
Government
Funder name
Peterborough and Stamford Hospitals NHS Foundation Trust R&D Department (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
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26049662