Femoral nerve blockade in hip fracture patients

ISRCTN	ISRCTN46653818
DOI	https://doi.org/10.1186/ISRCTN46653818
Protocol serial number	N/A
Sponsor	Umeå University (Sweden)
Funders	County Council of Västerbotten (Västerbottens läns landsting [VLL]) (Sweden), Umeå University (Sweden)

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

Operationscentrum
Norrlands universitetssjukhus
Umea
SE-901 85
Sweden

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	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

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes