Femoral nerve blockade in hip fracture patients
| ISRCTN | ISRCTN46653818 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46653818 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/03/2009
- Registration date
- 05/05/2009
- Last edited
- 05/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Prof Ola Winso
Scientific
Scientific
Operationscentrum
Norrlands universitetssjukhus
Umea
SE-901 85
Sweden
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Femoral nerve blockade in hip fracture patients: a randomised controlled trial |
| Study objectives | Femoral nerve blockade reduces pain and the need of opioids and therefore also post-operative delirium and complications in hip fracture patients. |
| Ethics approval(s) | Ethical Committee of the Faculty of Medicine at Umea University approved on the 7th October 2008 (ref: 08-121M) |
| Health condition(s) or problem(s) studied | Hip fracture |
| Intervention | Patients are randomised to femoral nerve blockade or the regular use of opioids. Both groups will receive 1 g of paracetamol 4 times/day. The patients in the intervention group will receive a femoral nerve blockade as soon as they arrive at the Orthopaedic Department. If the patients in the intervention group assess pain according to Visual Analogue Scale (VAS) more than 4 then they will be given morphine intravenously (iv) according to the standard protocol (morphine 10 mg/ml, 1 - 5 mg when necessary). Patients in the control group will be given morphine iv according to the standard protocol when they assess pain according to VAS more than 4 but no blockade (morphine 10 mg/ml, 1 - 5 mg when necessary). Post-operative pain treatment will be given according to the standard protocol in both arms of the study. The total follow-up of the trial for both arms will end at the time of discharge. |
| Intervention type | Other |
| Primary outcome measure | 1. Post-operative delirium, assessed three times a day at the Orthopaedic Department 2. Post-operative complications, such as decubital ulcers, infections, thrombosis, heart failure, assessed three times a day at the Orthopaedic Department 3. Pain, assessed three times a day at the Orthopaedic Department A cognitive test will be assessed in the ambulance pre-hospitally and at 24 +/- 6 hours post-operatively. At days three to five a more thorough assessment will be done including delirium, depression, cognitive status, quality of life and more. |
| Secondary outcome measures | 1. Mortality 2. Orthopaedic recovery, recorded at the time of discharge from the hospital 3. EQ-5D 4. Economics A cognitive test will be assessed in the ambulance pre-hospitally and at 24 +/- 6 hours post-operatively. At days three to five a more thorough assessment will be done including delirium, depression, cognitive status, quality of life and more. |
| Overall study start date | 30/03/2009 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 250 |
| Key inclusion criteria | 1. Both males and females, aged 70 years and above 2. All hip fracture patients admitted to the Orthopaedic Department |
| Key exclusion criteria | 1. Local infection 2. Allergic to local anaesthesia 3. Dying patients 4. Pathologic hip fractures |
| Date of first enrolment | 30/03/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Operationscentrum
Umea
SE-901 85
Sweden
SE-901 85
Sweden
Sponsor information
Umeå University (Sweden)
University/education
University/education
-
Umea
SE-901 87
Sweden
| Website | http://www.umu.se/umu/index_eng.html |
|---|---|
"ROR" |
https://ror.org/05kb8h459 |
Funders
Funder type
Government
County Council of Västerbotten (Västerbottens läns landsting [VLL]) (Sweden)
No information available
Umeå University (Sweden)
No information available
Results and Publications
| 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 |
