Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000526279
Ethics application status
Approved
Date submitted
10/06/2009
Date registered
1/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound-guided femoral nerve block as a mode of analgesia in patients presenting with a hip fracture to the Emergency Department.
Scientific title
Ultrasound guided femoral nerve block using 1% ropivacaine as a method of pain control in patients who present to emergency with a fractured hip.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain management in patients who have a radiological diagnosis of fractured neck of femur who present to the emergency department. 236968 0
Condition category
Condition code
Injuries and Accidents 237315 237315 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An ultrasound guided femoral nerve block will be placed using 1% ropivacaine. We are testing it's ability to provide pain control for patients with fractured neck of femurs.
Any emergency registrar or consultant who has been enlisted as an investigator and has undergone the training session is able to enrol patients and administer the block. After written informed consent has been obtained by the patient the groin area is prepared with sterile technique. An ultrasound vascular probe is placed to locate structures anatomically: the main structures being the femoral nerve itself, the femoral artery and vein, the fascia iliaca. Then under real time ultrasound guidance via an out of plane approach 15ml of 1% ropivacaine is injected around the femoral nerve as visualised. A two person technique is employed with the needle attached to the syringe of ropivacaine via a 90cm minimum volume extension set. There is the probe and needle operator and the an assistant injecting the anaesthetic. Digital pressure is then placed for 30 seconds just distal to the injection site. The entire procedure takes about 15 to 20 minutes. Objective measure of the nerve block is assessed at 30 minutes by testing sensation over the anterolateral aspect of the thigh.
Intervention code [1] 236740 0
Other interventions
Comparator / control treatment
Both the study and control group will receive regular oral tablet paracetamol 1g every 4 to 6 hours to a maximum dose of 4g/ in 24hours and parenteral (intravenous) morphine as required for pain control. The study group will also receive a ultrasound guided femoral nerve block. We will compare morphine usage in both groups.
Control group
Active

Outcomes
Primary outcome [1] 238128 0
Morphine use in patients for both groups.
Timepoint [1] 238128 0
We are assessing morphine usage over the first 24hours of their hospital admission. That is from the time of presenting to the emergency department. Any morphine given by the ambulance service will also be included in this first 24hour period.
Secondary outcome [1] 242335 0
Pain scores and subsequent pain scores will be looked at in each group and compared over the first 12 hours. The score will be from 0 to 10, 10 being the worst pain.
Timepoint [1] 242335 0
Pain scores in both groups will be assessed: at enrolment into the study, 30 minutes after enrolment or after nerve block has been given then at 4 then 8 then 12 hours after enrolment.

Eligibility
Key inclusion criteria
Radiological proof of a fractured neck of femur.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
2. <18years old.
3. Allergy to ropivacaine.
4. Allergy to paracetamol and morphine.
5. Anticogulated patients or those with significant coagulation abnormalities that increase their risk of bleeding.
6. localized injection site infections.
7. neurological deficits in the distribution of the femoral nerve noted.
8. Consent denied.
9. Documented severe hepatic disease
patient is unable to give consent themselves.
10. patients with a history of heart block or who are on amiodarone
11. patients who have had an acute cardiac event in the last 3 months.

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 need to have radiological proof of fractured neck of femur. They also have to be able to provide their own consent. They are then approached by an investigator and the study and it's purposes discussed. If they are willing to participate - an envelope is randomly taken out of a randomisation box. Inside the envelope is the decision as to which group the patient has been randomised to. The box contains equal numbers of envelopes for the randomisation to both the study and control groups.
The patient will not be blinded to which group they have been allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients who are willing to be involved will be enrolled as they are diagnosed with radiological proof of fractured neck of femur. Each will be randomised to either the control or study group throughout the study period.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237136 0
Hospital
Name [1] 237136 0
St Vincents Hospital
Country [1] 237136 0
Australia
Primary sponsor type
Hospital
Name
St Vincents
Address
Victoria Street
Darlinghurst 2010
New South Wales
Country
Australia
Secondary sponsor category [1] 4626 0
None
Name [1] 4626 0
Address [1] 4626 0
Country [1] 4626 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239229 0
St Vincents Hospital Human Reseach Ethics Committes
Ethics committee address [1] 239229 0
Victoria Street
Darlinghurst 2010
New South Wales
Ethics committee country [1] 239229 0
Australia
Date submitted for ethics approval [1] 239229 0
Approval date [1] 239229 0
17/03/2009
Ethics approval number [1] 239229 0
HREC/08/SVH/186

Summary
Brief summary
We are examining pain management in those patients who present to the emergency department with a fractured hip. Current practice in St Vincent's hospital emergency department is regular paracetamol and parenteral morphine. The POTENTIAL side effects of morphine are well known particularly in the older age group and include such effects as: drowsiness and/or confusion; nausea and vomiting; clinical significant slowing of breathing and lowering of blood pressure. Particular in those who receive significant amounts of morphine.

Our aim is to show that patients who receive an ultrasound guided femoral nerve block AS PART OF their pain control management will require clinically significant less morphine than those who do not. In fact we are hoping to show these patients use 50% less morphine. If this is the case we will be supporting the idea of introducing ultrasound guided femoral nerve blocks to current clinical practice guidelines for managing pain in fractured hips.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29727 0
Address 29727 0
Country 29727 0
Phone 29727 0
Fax 29727 0
Email 29727 0
Contact person for public queries
Name 12974 0
Dr Edmond Park
Address 12974 0
Emergency Department
St Vincents Hospital
Victoria Street
Darlinghurst 2010
New South Wales
Country 12974 0
Australia
Phone 12974 0
+61 2 8382 2040
Fax 12974 0
+61 2 8382 3957
Email 12974 0
[email protected]
Contact person for scientific queries
Name 3902 0
Dr Edmond Park
Address 3902 0
Emergency Department
St Vincents Hospital
Victoria Street
Darlinghurst 2010
New South Wales
Country 3902 0
Australia
Phone 3902 0
+61 2 8382 2040
Fax 3902 0
+61 2 8382 3957
Email 3902 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.