Condition category
Injury, Occupational Diseases, Poisoning
Date applied
25/10/2012
Date assigned
26/10/2012
Last edited
02/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hip fracture is one of the most serious injuries that occur in older people. These fractures are very painful and traditionally require potent analgesia (painkillers), which are effective but have side effects including nausea, vomiting, constipation and confusion. The patient may then refuse treatment and remain in pain, or in some cases remain pain-free if they lie in bed, but struggle when walking. Techniques which directly involve numbing the nerves around the hip have been proposed as an alternative and practical method of reducing pain when moving and at rest. However, no study has evaluated numbing of the main nerve in the leg (called femoral nerve block), its effects on overall pain control, and its acceptability to staff and patients compared with standard analgesia. The aim of this study is to find out whether femoral nerve block controls pain more effectively compared to standard analgesia.

Who can participate?
Patients aged 70 and over with an acute hip fracture.

What does the study involve?
Participants are randomly allocated to be treated with either a femoral nerve block or standard analgesia.

What are the possible benefits and risks of participating?
We expect that femoral nerve block will result in fewer side effects, earlier recovery, shorter length of stay in hospital and improved quality of life for patients suffering with an acute hip fracture. The most commonly reported side effects of the drugs used for the femoral nerve block are: low blood pressure, nausea, anaemia, vomiting, dizziness, headache, fever, procedural pain, back pain, and ‘pins and needles’.

Where is the study run from?
Queens Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.

When is the study starting and how long is it expected to run for?
January 2012 to December 2012.

Who is funding the study?
Nottingham University Hospitals NHS Trust (UK).

Who is the main contact?
Prof. Opinder Sahota
opinder.sahota@nuh.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Opinder Sahota

ORCID ID

Contact details

Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
-
opinder.sahota@nuh.nhs.uk

Additional identifiers

EudraCT number

2010-023871-25

ClinicalTrials.gov number

Protocol/serial number

10929

Study information

Scientific title

The FINOF - Femoral nerve-block Intervention in Neck Of Femur fracture study

Acronym

FINOF

Study hypothesis

Hip fracture is one of the most serious injuries that occur in older people. These fractures are very painful and traditionally require potent opioid/opioid related analgesia, which although effective, has undesired adverse events.

Common side-effects include nausea, vomiting, constipation, and more infrequently, but importantly, delirium. Patient may then refuse treatment and remain in pain or in some cases find if they lie in bed, remain pain-free, but struggle during ambulation. This leads to further complications, impaired rehabilitation and prolonged hospital stay.

Techniques which directly involve numbing the nerves around the hip, have been proposed as an alternative and practical method of alleviating both rest and dynamic pain (important when patients are being transferred or ambulating). However no study has evaluated numbing of the main nerve in the leg (femoral nerve) and the effects on overall pain control, rehabilitation and issues of compliance, acceptability to staff / patients compared to standard analgesic regimes.

We plan to undertake a 12 month randomised controlled study of 150 elderly patients admitted with an acute hip fracture. Subjects on admission, following informed consent will be randomly allocated to a nerve block, followed by a continuous nerve block infusion or standard analgesic care.

We envisage nerve block analgesia compared to conventional analgesia will result in fewer drug related adverse events, earlier recovery, shorter length of stay in hospital and overall, improved quality of life for patients suffering with an acute hip fracture.

Acceptability and implementation will be measured by semi-structured interviews with both staff and patients focusing around pain (patient group) and ease of use (staff group) which will help the implementation of these findings across the country.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=10929

Ethics approval

Nottingham Research Ethics Committee 2, 28/01/2011, ref: 10/H0408/113

Study design

Randomised controlled study

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

1. Standard analgesic care
2. Femoral nerve block followed by insertion of a femoral catheter and continous femoral nerve block

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Cumulative dynamic pain score
2. Cumulative ambulation score

Measured from day 1 to day 3 post operatively

Secondary outcome measures

1. Cumulative dynamic pain score preoperatively ( at 30 mins, 60 mins, 12 hours following the initial femoral nerve block)
2. Cumulative side effects (nausea, vomiting, constipation, delirium) (from admission to day three post-operatively)
3. Cumulative calorific and protein intake (from admission to day 3 post-operatively)
4. Health related quality of life, measured using the EUROQOL EQ-5D (14) informing a cost effectiveness analysis
5. Hospital length of stay
6. Rehabilitation outcome, measured by New Mobility Score
7. Participant and staff experience (qualitative study)

Overall trial start date

02/01/2012

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 70 years and over
2. Resident in their own home or warden aided flat
3. Patients who are cognitively intact [as defined by a score of seven or more on the Abbreviated 10 point Mental Test Score (AMTS)
4. A prior fracture New Mobility Score of 3 or more (indicating independent indoor ambulation)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 150; UK Sample Size: 150

Participant exclusion criteria

1. Prefracture hospitalisation
2. Contraindications to femoral nerve block analgesia
3. Regular prefracture opioid or glucocorticoid therapy
4. Alcohol or substance abuse
5. Morphine intolerance, and postoperative surgical restrictions for ambulation

Recruitment start date

02/01/2012

Recruitment end date

31/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust (UK)

Sponsor details

MRC Institute of Hearing Research Nottingham Clinical Section
Eye Ear Nose and Throat Centre
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.nuh.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)

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

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24885267

Publication citations

  1. Protocol

    Sahota O, Rowlands M, Bradley J, Van de Walt G, Bedforth N, Armstrong S, Moppett I, Femoral nerve block Intervention in Neck of Femur fracture (FINOF): study protocol for a randomized controlled trial., Trials, 2014, 15, 189, doi: 10.1186/1745-6215-15-189.

Additional files

Editorial Notes