ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Fractured neck of femur

Hip fracture

Condition category

Condition code

Anaesthesiology

Pain management

Emergency medicine

Other emergency care

Injuries and Accidents

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Post operative Day 5

Secondary outcome [1]

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]

During admission

Secondary outcome [2]

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]

Discharge from hospital

Secondary outcome [3]

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]

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?

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]

2010 - Darlinghurst

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St Vincent's Hospital, Sydney, NSW, Australia

Address [1]

390 Victoria St, Darlinghurst, Sydney, NSW, Australia 2010

Country [1]

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]

Hospital

Name [1]

St Vincent's Hospital, Sydney

Address [1]

390 Victoria St, Darlinghurst, Sydney, NSW, 2010

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Human Research Ethics Committee

Ethics committee address [1]

390 Victoria St, Darlinghurst, Sydney, NSW, Australia 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/06/2019

Approval date [1]

03/07/2019

Ethics approval number [1]

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

Dr Jennifer Stevens

Address

St Vincent's Hospital, Sydney
390 Victoria St, Darlinghurst, Sydney, NSW, Australia 2010

Country

Australia

Phone

+612 8382 1111

Fax

[email protected]

Contact person for public queries

Name

Benjamin Tassie

Address

St Vincent's Hospital, Sydney
390 Victoria St, Darlinghurst, Sydney, NSW, Australia 2010

Country

Australia

Phone

+61 2 8382 1111

Fax

[email protected]

Contact person for scientific queries

Name

Benjamin Tassie

Address

St Vincent's Hospital, Sydney
390 Victoria St, Darlinghurst, Sydney, NSW, Australia 2010

Country

Australia

Phone

+61 2 8382 1111

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Currently completing data analysis

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Increased opioid consumption after regional nerve blockade: association of fascia iliaca block with rebound pain in neck of femur fracture.	2021	https://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.

Trial Review

Documents added manually

Documents added automatically