Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000067370
Ethics application status
Approved
Date submitted
15/01/2008
Date registered
6/02/2008
Date last updated
6/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound Guided Three-in-One Nerve Block for the Relief of Acute Pain from Fractured Neck of Femur. A Double-Blind, Randomised, Controlled Trial.
Scientific title
In patients attending the Emergency Department with a fractured neck of femur,
does performing an Ultrasound guided three-in-one nerve block with bupivacaine lead to reduced pain scores and morphine requirements.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractured Neck of Femur. 2722 0
Condition category
Condition code
Anaesthesiology 2842 2842 0 0
Pain management
Injuries and Accidents 2843 2843 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twenty millilitres of long acting local anaesthetic or placebo is instilled around the femoral nerve on the side of the fractured neck of femur. Distal pressure is applied to ensure the local anaesthetic spreads upwards in the fascial plane to involve the obturator nerve and lateral cutaneous nerve of thigh. Ultrasound guidance of the needle is used to ensure accurate injection, while minimising the risk of damage to the nerve or injection of local anaesthetic into the blood vessels. Aseptic technique is used.Patients will receive either 0.5% bupivacaine or normal saline. These will be pre-prepared so that medical and nursing staff and patients will be ‘blind’ as to whether the local anaesthetic or placebo is injected. Bupivacaine is slow acting and therefore does not sting on injection as rapid acting lignocaine does.
Intervention code [1] 2460 0
Treatment: Drugs
Comparator / control treatment
Placebo – patients will be randomised to receive either 20ml of 0.9% saline which is expected to have no analgesic effect (placebo) or 20ml of 0.5% bupivacaine (local anaesthetic)The method of administration – by ultrasound guided injection under aseptic conditions will be identical for placebo and local anaesthetic.
Control group
Placebo

Outcomes
Primary outcome [1] 3727 0
Morphine requirements for analgesia
Timepoint [1] 3727 0
The first 16 hours after three-in-one nerve block or until operation if earlier.
Primary outcome [2] 3728 0
Pain scores as reported to nursing staff by patients on a zero to ten scale.
Timepoint [2] 3728 0
The first 16 hours after three-in-one nerve block or until operation if earlier.
Secondary outcome [1] 6291 0
Sedation Scores range from zero i.e. awake, to three i.e. difficult to rouse.
Timepoint [1] 6291 0
The first 16 hours after three-in-one nerve block or until operation if earlier.
Secondary outcome [2] 6292 0
Anti-emetic requirements for nausea
Timepoint [2] 6292 0
The first 16 hours after three-in-one nerve block or until operation if earlier.
Secondary outcome [3] 6293 0
Respiratory rate decreased below 12 breaths per minute.
Timepoint [3] 6293 0
The first 16 hours after three-in-one nerve block or until operation if earlier.

Eligibility
Key inclusion criteria
Patients with a fractured neck of femur within the past 48 hours presenting to the emergency department with pain or unable to weight bear.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Localised soft tissue infection at site of injury. Coagulopathy due to warfarin or any other cause with an INR greater than 3. Abbreviated Mental Test Score less than 7 out of 10 or patient otherwise without capacity to consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be informed of the study by one of the nurses and given an information sheet. If interested in participation, one of the doctors who would perform the procedure will explain further and obtain consent for inclusion. The consent form includes an abbreviated mental test (score greater than seven required) and a separate three question assessment of capacity to consent. Numbered syringes will be prepared in advance by the pharmacy department. These will all contain either 20ml of 0.5% bupivacaine or 20ml of 0.9% saline. The syringes will not be marked regarding their contents. These are both clear, colourless liquids with no odour and minimal discomfort on injection. They will be stored in refridgeration in the Emergency department for up to 4 weeks. The contents of each syringe will only become known to investigators in the analysis of data, well after the 16 hours of follow-up for each patient. The researcher taking the next syringe from refridgeration will have no way of knowing which solution it contains.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The pharmacy department will make up the syringes in batches of 20 – each containing 10 of saline and 10 of bupivacaine. These will be numbered with a computer generated random number. The list with details of which syringes contained which solution will be kept secret until after data on primary and secondary outcomes is collated. The randomisation process is done prior to preparation of the syringes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 556 0
2305

Funding & Sponsors
Funding source category [1] 2975 0
Hospital
Name [1] 2975 0
Emergency Department, John Hunter Hospital.
Country [1] 2975 0
Australia
Primary sponsor type
Individual
Name
Dr James Cameron, FCEM.
Address
John Hunter Hospital Emergency Department, Lookout Road, New Lambton Heights, NSW, 2305
Country
Australia
Secondary sponsor category [1] 2682 0
Individual
Name [1] 2682 0
Dr Conrad Loten, FACEM
Address [1] 2682 0
John Hunter Hospital Emergency Department, Lookout Road, New Lambton Heights, NSW, 2305
Country [1] 2682 0
Australia
Secondary sponsor category [2] 2683 0
Individual
Name [2] 2683 0
Dr Mark Miller, FACEM
Address [2] 2683 0
John Hunter Hospital Emergency Department, Lookout Road, New Lambton Heights, NSW, 2305
Country [2] 2683 0
Australia
Other collaborator category [1] 156 0
Individual
Name [1] 156 0
Dr Chris Cahill
Address [1] 156 0
Emergency Department, Maitland Hospital, 550-560 High Street, Maitland
Country [1] 156 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4931 0
Hunter New England Research Ethics Unit
Ethics committee address [1] 4931 0
Locked Bag 1, NEW LAMBTON, NSW 2305
Ethics committee country [1] 4931 0
Australia
Date submitted for ethics approval [1] 4931 0
30/07/2007
Approval date [1] 4931 0
14/09/2007
Ethics approval number [1] 4931 0
ECO0403

Summary
Brief summary
This study is of pain relief for people with a broken hip (fractured neck of femur) in the period between arriving at the Emergency Department and having an operation. Standard treatment of pain is by injections of morphine as required. This study will look at injecting long acting local anaesthetic to the nerves which supply the hip. An ultrasound machine will be used to accurately place the injection. It is hoped that this will give better pain relief than morphine alone with less side effects of nausea and drowsiness. The local anaesthetic is expected to last about 18 hours. This will cover the period from the Emergency Department to Operating Theatre for many patients. Doctors, Nurses and Patients will not know whether local anaesthetic or a saline placebo has been injected. All patients will be given as much morphine as is necessary to control their pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28303 0
Address 28303 0
Country 28303 0
Phone 28303 0
Fax 28303 0
Email 28303 0
Contact person for public queries
Name 11460 0
Dr James Cameron
Address 11460 0
Emergency Department, John Hunter Hospital, Lookout Road, New Lambton Heights, Newcastle, NSW.
Country 11460 0
Australia
Phone 11460 0
02 49213000
Fax 11460 0
Email 11460 0
james.cameron@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 2388 0
Dr James Cameron
Address 2388 0
Emergency Department, John Hunter Hospital, Lookout Road, New Lambton Heights, Newcastle, NSW.
Country 2388 0
Australia
Phone 2388 0
02 49213000
Fax 2388 0
Email 2388 0
james.cameron@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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