Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000789864
Ethics application status
Approved
Date submitted
26/04/2021
Date registered
23/06/2021
Date last updated
23/12/2021
Date data sharing statement initially provided
23/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of dexamethasone on duration of analgesia from fascia iliaca compartment blocks in emergency department patients with hip fractures
Scientific title
Effect of intracompartmental dexamethasone on the duration of infra-inguinal ultrasound guided fascia iliaca compartment block performed in the emergency department on adult patients with hip fractures: a double blind randomised controlled trial
Secondary ID [1] 304064 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 321707 0
Fascia Iliaca Compartment Block 322148 0
Condition category
Condition code
Emergency medicine 319452 319452 0 0
Other emergency care
Musculoskeletal 319840 319840 0 0
Other muscular and skeletal disorders
Injuries and Accidents 319841 319841 0 0
Fractures
Anaesthesiology 319842 319842 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to assess the duration of analgesia gained from plain ropivacaine ultrasound guided fascia iliaca compartment block (USG-FICB) as compared to ropivacaine USG-FICB augmented by intracompartmental dexamethasone.

Enrolled patients will be randomised to receive an USG-FICB with either ropivacaine + dexamethasone OR ropivacaine + placebo. Duration of analgesia will be assessed based on timing of breakthrough opioid following the USG-FICB.

An external third party will prepare syringes containing 1 mL of either normal saline or 1 mL of dexamethasaone 4mg/mL. They will be labelled such that blinding can be maintained. e.g. "A" or "B", in identical syringes.

150 mg of ropivacaine will be diluted into 39 mL of 0.9% saline. If randomised to intervention, 1 mL of 4mg/mL dexamethasone (blinded) will be added to this syringe. This will result in a 0.375% ropivacaine and 0.1 mg/mL dexamethasone solution. If a patient weighs less than 60 kg, 30 mL of this solution will be injected into the compartment. If the patient weighs 60-70 kg, 35 mL of this solution will be injected into the compartment. If the patient weighs more than 70 kg, 40 mL of this solution will be injected into the compartment.

This intervention will only occur once, close to the time of presentation and randomisation.

As noted above, the dexamethasone and ropivacaine will be administered at the same time, in the same syringe.

The person performing the intervention will be an emergency department doctor trained in the procedure and study protocol. Administration will be recorded in the electronic medical record, including the random allocation to "A" or "B".
Intervention code [1] 320386 0
Treatment: Drugs
Comparator / control treatment
The control group will receive standard care with ropivacaine as a single agent in the USG-FICB.

150 mg of ropivacaine will be diluted into 39 mL of 0.9% saline. If randomised to control 1 mL of 0.9% saline (blinded) will be added to this syringe. This will result in a 0.375% ropivacaine solution. If a patient weighs less than 60 kg, 30 mL of this solution will be injected into the compartment. If the patient weighs 60-70 kg, 35 mL of this solution will be injected into the compartment. If the patient weighs more than 70 kg, 40 mL of this solution will be injected into the compartment.

This method will result in the placebo and ropivacaine being injected at the same time.
Control group
Placebo

Outcomes
Primary outcome [1] 327317 0
Duration of analgesia
Timepoint [1] 327317 0
Time to opioid rescue analgesia from 30 minutes post USG-FICB – as logged on the electronic medical record (eMR)
Secondary outcome [1] 394595 0
Opioid (morphine equivalents) consumption
Timepoint [1] 394595 0
preoperatively, or within 24 hours of admission, whichever is shorter – as logged on the eMR.
Secondary outcome [2] 394596 0
Naloxone use
Timepoint [2] 394596 0
preoperatively, or within 24 hours of admission, whichever is shorter – as logged on the eMR.
Secondary outcome [3] 394597 0
Antiemetic use
Timepoint [3] 394597 0
preoperatively, or within 24 hours of admission, whichever is shorter – as logged on the eMR
Secondary outcome [4] 394598 0
Pain at rest as measured by numerical rating scale (NRS)
Timepoint [4] 394598 0
measured at 30 and 60 minutes post USG-FICB.

Eligibility
Key inclusion criteria
1. Male and female patients with a radiographically confirmed hip fracture
2. Age greater than or equal to 18 years
3. Emergency department triage between 07:30 and 23:59
4. Willing and able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Critically unwell patients
2. Fractures at multiple anatomical sites
3. Delirium
4. Severe cognitive impairment
5. Infection at the injection site
6. Previous femoral bypass surgery
7. Allergy to local anaesthetics
8. Chronic pain condition
9. Known polyneuropathy
10. History of opioid abuse
11. Pregnant or breastfeeding
12. No trained clinician available to perform the USG-FICB.

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)
The investigators, treating clinicians and the patient will be blinded.

An external party will prepare syringes containing 1 mL of 4 mg/mL dexamethasone or 1 mL of normal saline. The syringes will be coded as “A” or “B” to maintain blinding. The third party will not decipher the code until data analysis is complete.

A computer-generated list to randomise participants will be created prior to commencement of patient recruitment. Using this list, a series of allocation cards will be printed, and the original list will be stored securely. These allocations cards will be placed in sealed, numbered, opaque envelopes and stored in a locked office.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be block randomised according to a random computer-generated list from https://www.sealedenvelope.com/simple-randomiser/v1/lists . Block size will be eight. Assignments will be concealed in sealed opaque envelopes.
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
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Duration of analgesia from ropivacaine FICB has been reported as 4.85 ± 2.86 hours. We hope to increase duration of analgesia by 50% (that is 7.275 hours). Based on this, we assume effect size, d = 0.85. Assuming a power of 90% and two-sided alpha of 0.05, we estimate that 64 patients will be needed (32 in each group). We estimate a drop-out rate of 10% in this trial, therefore, we will require 72 patients (64 / 0.90 – that is 36 patients in each group).

Patients will be analysed according to their randomised treatment allocation, i.e. using an Intention to Treat (ITT) analysis.

Demographic data including age, sex, weight, height, co-morbidities, morphine equivalents pre FICB, type of hip fracture, and Glasgow Coma Scale (GCS), will be compared between groups using a t-test or Mann-Whitney U test for continuous data and Chi-squared or Fisher’s exact test for categorical data.

P values < 0.05 will be considered indicative of statistical significance and all analyses will be performed using IBM SPSS software.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/08/2021
Actual
28/10/2021
Date of last participant enrolment
Anticipated
2/07/2022
Actual
Date of last data collection
Anticipated
3/07/2022
Actual
Sample size
Target
72
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19202 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 33774 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 308406 0
Other Collaborative groups
Name [1] 308406 0
Green Light Institute for Emergency Care
Country [1] 308406 0
Australia
Primary sponsor type
Individual
Name
Bashir Chakar
Address
Royal Prince Alfred Hospital Emergency Department
Level 5, Building 63
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 309283 0
None
Name [1] 309283 0
Address [1] 309283 0
Country [1] 309283 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308368 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 308368 0
Ethics committee country [1] 308368 0
Australia
Date submitted for ethics approval [1] 308368 0
12/02/2021
Approval date [1] 308368 0
01/06/2021
Ethics approval number [1] 308368 0

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

Contacts
Principal investigator
Name 110466 0
Dr Bashir Chakar
Address 110466 0
Green Light Institute for Emergency Care
Royal Prince Alfred Hospital
Level 10, King George V Building
Missenden Road
Camperdown NSW 2050
Country 110466 0
Australia
Phone 110466 0
+61 02 9515 9085
Fax 110466 0
Email 110466 0
[email protected]
Contact person for public queries
Name 110467 0
Bashir Chakar
Address 110467 0
Green Light Institute for Emergency Care
Royal Prince Alfred Hospital
Level 10, King George V Building
Missenden Road
Camperdown NSW 2050
Country 110467 0
Australia
Phone 110467 0
+61 02 9515 9085
Fax 110467 0
Email 110467 0
[email protected]
Contact person for scientific queries
Name 110468 0
Bashir Chakar
Address 110468 0
Green Light Institute for Emergency Care
Royal Prince Alfred Hospital
Level 10, King George V Building
Missenden Road
Camperdown NSW 2050
Country 110468 0
Australia
Phone 110468 0
+61 02 9515 9085
Fax 110468 0
Email 110468 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication and ending 15 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator or data manager at the Green Light Institute for Emergency Care

The PI and the Data manager can be contacted via RPA switchboard on +612 9515 9085

The PI may be contacted by email via [email protected]


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.