Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001884291
Ethics application status
Approved
Date submitted
13/11/2018
Date registered
20/11/2018
Date last updated
5/03/2019
Date data sharing statement initially provided
20/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Better ways of pain management in adults with hip fractures
Scientific title
Neck Of Femur fracture pain management with ultrasound-guided single bolus versus repeated bolus Fascia Iliaca CatheterS in the Emergency Department: a double-blind, randomized controlled trial. (NOF-FICSED)
Secondary ID [1] 296095 0
None
Universal Trial Number (UTN)
Trial acronym
NOF-FICSED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Fracture Pain Management 309674 0
Cognitive Impairment 309675 0
Condition category
Condition code
Emergency medicine 308477 308477 0 0
Other emergency care
Surgery 309103 309103 0 0
Other surgery
Anaesthesiology 309104 309104 0 0
Pain management
Injuries and Accidents 309137 309137 0 0
Fractures
Neurological 309138 309138 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single vs repeated bolus fascia iliaca (FICB) nerve blocks from emergency department to surgery.

Arm 1: 40ml 0.2% Ropivacaine through a FICB catheter followed by 2hrly 20ml 0.2% Ropivacaine through the same FICB catheter until surgery. This duration maybe anywhere from 6 - 48 hours.
Arm 2: 40ml 0.2% Ropivacaine through a FICB catheter followed by 2hrly 20ml 0.9% saline through the same FICB catheter until surgery. This duration maybe anywhere from 6 - 48 hours.
Intervention code [1] 312436 0
Treatment: Drugs
Comparator / control treatment
Arm 2: 40ml 0.2% Ropivacaine through a FICB catheter and 2hrly 0.9% saline until surgery
Control group
Active

Outcomes
Primary outcome [1] 307457 0
Behavioural pain score (Pain in Advanced Dementia)
Timepoint [1] 307457 0
Pre-operation pain scores at 16 hours from emergency presentation (primary timepoint)

Other pain score timepoints will be as follows:
Every hour from emergency presentation for first 4 hours
Every 2 hours from hours 4-8
Every 4 hours from hours 8 until time to surgery.

Time to surgery duration may range from 6-48 hours with the average being 23 hours. Pain scores will be compared across multiple timepoints where applicable.
Secondary outcome [1] 351970 0
Pain Scale (verbal response scale 1-10)
Timepoint [1] 351970 0
Pre-operation pain scores at 16 hours from emergency presentation (secondary timepoint)

Other pain score timepoints will be as follows:
Every hour from emergency presentation for first 4 hours
Every 2 hours from hours 4-8
Every 4 hours from hours 8 until time to surgery.

Time to surgery duration may range from 6-48 hours with the average being 23 hours. Pain scores will be compared across multiple timepoints where applicable.
Secondary outcome [2] 353894 0
Total Opioid use (Study-specific analysis)
- Total Opioid use will be standardised to IV Morphine using the ANZFPM pain calculator, then divided by each patients weight (kg) and standardised to a 24 hour time period to allow appropriate comparison.
Timepoint [2] 353894 0
Total IV Morphine over entire duration (from 6-48 hours) standardised to amount/24 hours.
Secondary outcome [3] 353895 0
Delirium incidence (CAM Scores) - single incidence
Timepoint [3] 353895 0
Pre-operative time period. Duration may last from 6-48hours depending on surgical planning.

Eligibility
Key inclusion criteria
Adults over the age of 50 years with a radiologically-proven neck of femur fracture and ability to consent
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Interhospital transfers,
Refusal of consent,
Individuals with weights less than 50kg, Local site infection,
Allergies to local anaesthetics,
Liver failure,
Dangerous or combative patients,
Altered anatomy (such as past femoral bypass),
Unwell patients requiring immediate resuscitation

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)
Identical drug treatment bags provided by Ropivacaine supplier
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be via a permuted block of varying block size code generated by a validated computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Block Stratification for Fracture Type and for Cognitive Status
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
1/07/2020
Actual
Date of last data collection
Anticipated
1/09/2020
Actual
Sample size
Target
122
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12393 0
The Townsville Hospital - Douglas
Recruitment hospital [2] 13303 0
Mackay Base Hospital - Mackay
Recruitment hospital [3] 13304 0
Bundaberg Hospital - Bundaberg
Recruitment postcode(s) [1] 24660 0
4814 - Douglas
Recruitment postcode(s) [2] 25877 0
4740 - Mackay
Recruitment postcode(s) [3] 25878 0
4670 - Bundaberg

Funding & Sponsors
Funding source category [1] 300683 0
Hospital
Name [1] 300683 0
Townsville Hospital
Country [1] 300683 0
Australia
Primary sponsor type
Hospital
Name
Townsville Hospital
Address
100 Angus Smith Drive Douglas QLD, 4814
Country
Australia
Secondary sponsor category [1] 300780 0
None
Name [1] 300780 0
Address [1] 300780 0
Country [1] 300780 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301465 0
Townsville Hospital and Health Service Human Research Ethics Committee [EC00183]
Ethics committee address [1] 301465 0
100 Angus Smith Drive QLD 4814
Ethics committee country [1] 301465 0
Australia
Date submitted for ethics approval [1] 301465 0
22/08/2018
Approval date [1] 301465 0
31/10/2018
Ethics approval number [1] 301465 0
HREC/2018/QTHS/44969

Summary
Brief summary
The purpose of this study is to compare ultrasound guided repeat fascia iliaca blocks delivered through a catheter to ultrasound guided single blocks delivered through a catheter with a saline control in emergency department hip fracture patients. The outcomes measured will be behavioural pain scores, verbal pain scores, opioid use, and incidence of delirium. Further a health economic component will analyse cost effectiveness of both interventions. We predict based on the literature and a pilot study that repeated boluses will be less painful, use less opioids, and have decreased incidences of delirium.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87102 0
Dr Michael Polischuk
Address 87102 0
Townsville Hospital and Health Service
100 Angus Smith Drive, Douglas QLD 4814
Country 87102 0
Australia
Phone 87102 0
+61 7 44331111
Fax 87102 0
Email 87102 0
[email protected]
Contact person for public queries
Name 87103 0
Dr Michael Polischuk
Address 87103 0
Townsville Hospital and Health Service
100 Angus Smith Drive, Douglas QLD 4814
Country 87103 0
Australia
Phone 87103 0
+61 7 44331111
Fax 87103 0
Email 87103 0
[email protected]
Contact person for scientific queries
Name 87104 0
Dr Michael Polischuk
Address 87104 0
Townsville Hospital and Health Service
100 Angus Smith Drive, Douglas QLD 4814
Country 87104 0
Australia
Phone 87104 0
+61 7 44331111
Fax 87104 0
Email 87104 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
IPD data will likely be available to aid in reproducibility and comparison from other groups. Data released will not include confidential identifiable information.


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23690Study protocol    Will be uploaded at conclusion of study.

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEmergency Department Femoral Nerve Blocks and 1-Year Mortality in Fragility Hip Fractures2019https://doi.org/10.1177/2151459319893894
N.B. These documents automatically identified may not have been verified by the study sponsor.