Condition category
Musculoskeletal Diseases
Date applied
12/03/2007
Date assigned
13/08/2007
Last edited
10/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Martyn Parker

ORCID ID

Contact details

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

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

Publication citations

Additional files

Editorial Notes

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