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 |
| Protocol serial number | R&D/2007/08 |
| Sponsor | Peterborough and Stamford Hospitals NHS Foundation Trust (UK) |
| Funder | Peterborough and Stamford Hospitals NHS Foundation Trust R&D Department (UK) |
- Submission date
- 12/03/2007
- Registration date
- 13/08/2007
- Last edited
- 10/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Martyn Parker
Scientific
Scientific
Peterborough and Stamford Hospitals Foundation NHS Trust
Thorpe Road
Peterborough
PE3 6DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Pain will be assessed by asking open questions and performing an assessment of the amount of analgesia required. |
| Key secondary outcome measure(s) |
1. Mobility will be assessed by using a specially designed questionnaire |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Peterborough and Stamford Hospitals Foundation NHS Trust
Peterborough
PE3 6DA
United Kingdom
PE3 6DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2015 | Yes | No |
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
