Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001771145
Ethics application status
Approved
Date submitted
26/10/2019
Date registered
13/12/2019
Date last updated
13/12/2019
Date data sharing statement initially provided
13/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does performing a fascia iliaca block in patients with confirmed fractured neck of femur in the emergency department have an effect on post operative outcomes?
Scientific title
In-hospital outcome changes associated with fascia iliaca block after fractured neck of femur
Secondary ID [1] 300052 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractured neck of femur 314210 0
Hip fracture 315562 0
Condition category
Condition code
Anaesthesiology 312573 312573 0 0
Pain management
Emergency medicine 313856 313856 0 0
Other emergency care
Injuries and Accidents 313857 313857 0 0
Fractures

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Ultrasound guided fascia iliaca blocks performed in the emergency department by medical and nursing staff for analgesia following confirmed neck of femur fracture.

Retrospective descriptive cohort study. Chart audit until Day 5 post op and discharge data collected. Risk of harm to participants was considered low to negligible and explicit consent from participants was therefore not required by the ethics committee.
Intervention code [1] 315420 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322247 0
Post operative analgesia in oral morphine equivalence.
Medication chart will be used and all enteral and parenteral opioids will be converted into an oral morphine equivalent dose using the Faculty of Pain Medicine, ANZCA, Opioid Calculator.
Timepoint [1] 322247 0
Post operative Day 5
Secondary outcome [1] 374376 0
Rates of infection (soft tissue, urine, respiratory) during admission following neck of femur fracture and surgery
Microbiology and radiological results from the patient's file will be used to determine presence or absence of these 3 postoperative infections.
Timepoint [1] 374376 0
During admission
Secondary outcome [2] 377851 0
Discharge with slow release opioids prescribed. Discharge medication list will be used to identify slow acting opioids and the Faculty of Pain Medicine, ANZCA, Opioid Conversion tool will be used to convert this into an oral morphine equivalent dose.
Timepoint [2] 377851 0
Discharge from hospital
Secondary outcome [3] 377852 0
Rates of DVT/PE during admission following neck of femur fracture and surgery.
Radiology results (doppler ultrasound, nuclear medicine (V/Q scan) or CTPA) from the patient's file will be used to establish presence of DVT/PE.
Timepoint [3] 377852 0
Discharge from hospital

Eligibility
Key inclusion criteria
Admitted patients to single tertiary hospital with confirmed neck of femur fracture between June 2015 and June 2017
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Duration
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
All patients presenting to the ED with a fractured NOF between June 2015 and June 2017 will be identified from the DRG ‘fractured NOF’. A convenience sample will be used. It is anticipated that data from approximately 300 patients will be available
Descriptive statistics (frequencies) will be determined for all demographic and clinical characteristics. Pain scores will be dichotomised to ‘decrease’, ‘no change or increase’. Differences between the two groups (nurse-insertion versus doctor-insertion) will be compared using chi-tests for categorical data and t-tests for continuous variables

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2020
Actual
Date of last participant enrolment
Anticipated
10/01/2020
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 27700 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 303677 0
Hospital
Name [1] 303677 0
St Vincent's Hospital, Sydney, NSW, Australia
Country [1] 303677 0
Australia
Primary sponsor type
Individual
Name
Dr Jennifer Stevens
Address
St Vincent's Hospital, Sydney
390 Victoria St, Darlinghurst, Sydney, NSW, Australia 2010
Country
Australia
Secondary sponsor category [1] 303783 0
Hospital
Name [1] 303783 0
St Vincent's Hospital, Sydney
Address [1] 303783 0
390 Victoria St, Darlinghurst, Sydney, NSW, 2010
Country [1] 303783 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304199 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 304199 0
390 Victoria St, Darlinghurst, Sydney, NSW, Australia 2010
Ethics committee country [1] 304199 0
Australia
Date submitted for ethics approval [1] 304199 0
26/06/2019
Approval date [1] 304199 0
03/07/2019
Ethics approval number [1] 304199 0

Summary
Brief summary
The primary outcome of this study is to examine whether there is an observable reduction in post operative opioid analgesia required in patients who received a fascia iliaca block in the emergency department for their fractured neck of femur, compared to patients who did not.
Secondary outcomes of this study will examine whether a discernible difference between rates of infection and thromboembolic complications exists between these groups of patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96126 0
Dr Jennifer Stevens
Address 96126 0
St Vincent's Hospital, Sydney
390 Victoria St, Darlinghurst, Sydney, NSW, Australia 2010
Country 96126 0
Australia
Phone 96126 0
+612 8382 1111
Fax 96126 0
Email 96126 0
[email protected]
Contact person for public queries
Name 96127 0
Benjamin Tassie
Address 96127 0
St Vincent's Hospital, Sydney
390 Victoria St, Darlinghurst, Sydney, NSW, Australia 2010
Country 96127 0
Australia
Phone 96127 0
+61 2 8382 1111
Fax 96127 0
Email 96127 0
[email protected]
Contact person for scientific queries
Name 96128 0
Benjamin Tassie
Address 96128 0
St Vincent's Hospital, Sydney
390 Victoria St, Darlinghurst, Sydney, NSW, Australia 2010
Country 96128 0
Australia
Phone 96128 0
+61 2 8382 1111
Fax 96128 0
Email 96128 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval to share individual participant data was neither sought nor granted.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Currently completing data analysis

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIncreased opioid consumption after regional nerve blockade: association of fascia iliaca block with rebound pain in neck of femur fracture.2021https://dx.doi.org/10.1016/j.bja.2021.03.034
N.B. These documents automatically identified may not have been verified by the study sponsor.