Condition category
Injury, Occupational Diseases, Poisoning
Date applied
30/03/2009
Date assigned
05/05/2009
Last edited
05/05/2009
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

Prof Ola Winso

ORCID ID

Contact details

Operationscentrum
Norrlands universitetssjukhus
Umea
SE-901 85
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Femoral nerve blockade in hip fracture patients: a randomised controlled trial

Acronym

Study hypothesis

Femoral nerve blockade reduces pain and the need of opioids and therefore also post-operative delirium and complications in hip fracture patients.

Ethics approval

Ethical Committee of the Faculty of Medicine at Umea University approved on the 7th October 2008 (ref: 08-121M)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

30/03/2009

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, aged 70 years and above
2. All hip fracture patients admitted to the Orthopaedic Department

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

250

Participant exclusion criteria

1. Local infection
2. Allergic to local anaesthesia
3. Dying patients
4. Pathologic hip fractures

Recruitment start date

30/03/2009

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Sweden

Trial participating centre

Operationscentrum
Umea
SE-901 85
Sweden

Sponsor information

Organisation

Umeå University (Sweden)

Sponsor details

-
Umea
SE-901 87
Sweden

Sponsor type

University/education

Website

http://www.umu.se/umu/index_eng.html

Funders

Funder type

Government

Funder name

County Council of Västerbotten (Västerbottens läns landsting [VLL]) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Umeå University (Sweden)

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

Publication citations

Additional files

Editorial Notes