Randomised controlled trial to assess the difference of spinal anaesthesia versus general anaesthesia in hip replacement surgery

ISRCTN	ISRCTN36381516
DOI	https://doi.org/10.1186/ISRCTN36381516
Secondary identifying numbers	R&D/2007/08

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Martyn Parker
Scientific

Peterborough and Stamford Hospitals Foundation NHS Trust
Thorpe Road
Peterborough
PE3 6DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Randomised controlled trial to assess the difference of spinal anaesthesia versus general anaesthesia in hip replacement surgery
Study objectives	Spinal anaesthesia is as good as general anaesthesia in hip replacement surgery.
Ethics approval(s)	Hertfordshire 2 Research Ethics Committee, 05/02/2007, ref: 06/Q0204/137
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/2007
Completion date	31/12/2013

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	600
Key inclusion criteria	1. Acute hip replacement surgery 2. Aged greater than 49
Key exclusion criteria	1. Conservative treatment for hip fracture 2. Unsuitable for spinal or general anaesthesia
Date of first enrolment	01/04/2007
Date of final enrolment	31/12/2013

Peterborough and Stamford Hospitals Foundation NHS Trust

Peterborough
PE3 6DA
United Kingdom

Peterborough and Stamford Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Thorpe Road
Peterborough
PE3 6DA
England
United Kingdom

Website	http://www.peterboroughhospitals.co.uk/page_viewer.asp?category=Home&sid=8
"ROR"	https://ror.org/03kv8xc26

Government

Peterborough and Stamford Hospitals NHS Foundation Trust R&D Department (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2015		Yes	No

10/06/2016: Publication reference added,
08/05/2013: The anticipated end date for this trial was updated from 01/04/2010 to 31/12/2013