Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000504011
Ethics application status
Approved
Date submitted
12/06/2010
Date registered
18/06/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Paramedic performed fascia iliaca compartment block for patients with suspected femoral fractures; A randomised controlled trial.
Scientific title
The feasibility and efficacy of paramedics performing fascia iliaca compartment blocks (FICB) in the prehospital setting for pain management in adult patients with suspected or confirmed femoral fractures: A randomised controlled trial.
Secondary ID [1] 252000 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management of Femoral fractures in pre hospital evironment. 257563 0
Condition category
Condition code
Anaesthesiology 257721 257721 0 0
Pain management
Injuries and Accidents 257722 257722 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anterior lumbar plexus nerve block (regional nerve block) known as a “fascia iliaca compartment block”.
This procedure involves a single insertion of needle in a specified anatomical location in the groin, distal to recognised neurovascular areas. A single bolus of local anaesthetic agent (Lignocaine 2% with Adrenaline 1:200 000) is injected slowly over 3 minutes into the potential space under the fascia iliaca and spread to anaesthetise the sensory nerves innervating the thigh. Dose weight dependant : <70 Kg 300mg and >70 Kg 400mg.

All patients consenting to partcipate in the study will receive a loading dose of 0.1 mg/Kg of morphine intravenously (I.V) in 2.5 mg aliquots.
Intervention code [1] 256652 0
Treatment: Drugs
Intervention code [2] 256653 0
Treatment: Other
Intervention code [3] 256654 0
Other interventions
Comparator / control treatment
Patients randomised into the controlled group will only receive (after the initial loading dose of morphine) further increments of morphine (2.5 mg every 2 minutes) until pain free at rest or to a maximum dose of 0.5mg/kg.
Patients randomised to the intervention group will not receive further morphine (after initial loading dose) until assessment of the outcome 15 minutes post completion of the fascia iliaca compartment block (FICB).
Control group
Active

Outcomes
Primary outcome [1] 258614 0
Primary outcome: Change in Verbal Numerical Pain Score(VNPS).
Timepoint [1] 258614 0
Time point: First contact with patient record VNPS (prior to any analgesia) and 15 minutes after either
a) initial morphine dose (control patients) or
b) following injection of local anaesthetic agent (treatment group).
Secondary outcome [1] 264531 0
Changes in VNPS on arrival at hospital.
Timepoint [1] 264531 0
Time point: Change in VNPS from the second (15 min time point) pain assessment.
Secondary outcome [2] 264532 0
VNPS at triage in emergency department.
Timepoint [2] 264532 0
Time point: independent assessment of VNPS by Triage Nurse.
Secondary outcome [3] 264533 0
VNPS on movement.
Timepoint [3] 264533 0
Time point: On movement of the patient from the ambulance stretcher to hospital bed.
Secondary outcome [4] 264534 0
Functional sensory deficit will be conduct 15 and 120 minutes and post FICB intervention.

Patients who receive the FICB will also be asked to determine or assess the level sensory cold perception in three areas of the effected thigh (medial. anterior and lateral aspects). Paramedics will use an ice pack and using other body areas as a base line ask the patients to determine their level of cold perception following FICB intervention.
Timepoint [4] 264534 0
Time point: This will be assessed at interval of 15 mins post FICB and at 120 mins.
Secondary outcome [5] 264535 0
Patient satisfaction of procedures
Timepoint [5] 264535 0
Time point: Patient will be asked to rate their satisfaction level of either analgesic method using a Likert Scale after 120 mins.
Secondary outcome [6] 264536 0
Paramedic rating of the FICB procedure
Timepoint [6] 264536 0
Time point: On completion of case paramedic will rate the procedure using a Likert Scale.
Secondary outcome [7] 264537 0
Recording any adverse events. For example; nausea, vomiting, additional pain, paraesthesia, haematoma and dysrhthmias.
Timepoint [7] 264537 0
Time point: Paramedics will record any adverse events following either intervention after 120 mins.

Eligibility
Key inclusion criteria
Adult patients (18+) with suspected femur fractures with moderate or severe pain (VNPS >4).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Failure to give consent.
Local infection at site.
Major trauma.
Cognitive impairment
Known hypersensitivity to anaesthetic agent or antidote.
Currently on oral anticoagulants – warfarin
Inability to identify landmarks ( i.e. obesity / pregnancy)
Estimate weight < 50 kg
Pre-existing nerve injury.

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)
Sealed opaque envelopes at point of care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequenced generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2010
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] 3001 0
2340

Funding & Sponsors
Funding source category [1] 257132 0
Government body
Name [1] 257132 0
New South Wales Health. Ambulance Service NSW
Country [1] 257132 0
Australia
Primary sponsor type
Government body
Name
New South Wales Health. Ambulance Service NSW
Address
Ambulance Research Institute.
Church Street Rozelle
Sydney, NSW. 2039
Australia
Country
Australia
Secondary sponsor category [1] 256389 0
University
Name [1] 256389 0
Charles Sturt University
Address [1] 256389 0
Boorooma Street
Wagga Wagga
NSW, 2678
Country [1] 256389 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259170 0
South Western Sydney Area Health Service Ethics Review Committee.
Ethics committee address [1] 259170 0
Ethics committee country [1] 259170 0
Australia
Date submitted for ethics approval [1] 259170 0
Approval date [1] 259170 0
10/02/2010
Ethics approval number [1] 259170 0
X09-0269

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31285 0
Address 31285 0
Country 31285 0
Phone 31285 0
Fax 31285 0
Email 31285 0
Contact person for public queries
Name 14532 0
Paul McRae
Address 14532 0
197 Marius Street
Tamworth, 2340 NSW.
Australia.
Country 14532 0
Australia
Phone 14532 0
+61 2 67668462
Fax 14532 0
Email 14532 0
[email protected]
Contact person for scientific queries
Name 5460 0
Paul McRae
Address 5460 0
197 Marius Street
Tamworth, 2340 NSW.
Australia.
Country 5460 0
Australia
Phone 5460 0
+61 2 67668462
Fax 5460 0
Email 5460 0
[email protected]

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.