Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001237572p
Ethics application status
Not yet submitted
Date submitted
20/09/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective, Non-Inferiority Randomised Trial Evaluating Regional Anaesthesia and Ankle Block for Acute Pain Control of Operatively Treated Ankle Fractures
Scientific title
Regional anaesthesia (popliteal and saphenous nerve block) versus ankle block for acute post-operative pain following ankle fracture fixation (APPLE): a single blinded, non-inferiority randomised controlled trial
Secondary ID [1] 313018 0
None
Universal Trial Number (UTN)
Trial acronym
APPLE: Ankle fracture Postoperative Pain Local Anaesthetic
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle fracture 335216 0
Condition category
Condition code
Musculoskeletal 331768 331768 0 0
Other muscular and skeletal disorders
Injuries and Accidents 331882 331882 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a single ultrasound guided popliteal and saphenous nerve block with 20ml 0.2% Ropivacaine diluted to 40ml (20ml normal saline) performed prior to the sterile preparation and draping before incision and surgical procedure (approximately 10 minutes prior). The anaesthetist completing the regional anaesthesia will be required to complete a form confirming adherence to study protocol and injection of the regional anaesthesia.
Intervention code [1] 329564 0
Treatment: Drugs
Comparator / control treatment
The comparator is a single ankle block performed with 20ml 0.2% Ropivacaine diluted to 40ml (20ml normal saline) prior to the sterile preparation and draping before incision and surgical procedure (approximately 10 minutes prior). The surgeon completing the ankle block will be required to complete a form confirming adherence to study protocol and injection of the ankle block.
Control group
Active

Outcomes
Primary outcome [1] 339423 0
Pain
Timepoint [1] 339423 0
Our primary outcome variable will be a repeated measures comparisons of VAS pain measured at 1, 2, 4, 6, 24, 48, and 72 hours after post-operatively. A repeated measure analysis is used as we care about the patients experience over the entire time period and not just a discrete time point.
Secondary outcome [1] 439895 0
Pain
Timepoint [1] 439895 0
Likert pain scale scores will be measured at 1, 2, 4, 6, 24, 48, and 72 hours after post-operatively
Secondary outcome [2] 439896 0
Length of stay
Timepoint [2] 439896 0
This outcome will be measured immediately after discharge from hospital
Secondary outcome [3] 439897 0
Total morphine equivalent
Timepoint [3] 439897 0
72 hours postoperatively
Secondary outcome [4] 439898 0
Activity levels - ankle specific
Timepoint [4] 439898 0
3 months postoperative
Secondary outcome [5] 439899 0
Activity levels
Timepoint [5] 439899 0
3 months postoperative
Secondary outcome [6] 440465 0
Time taken to perform regional anaesthesia and ankle block
Timepoint [6] 440465 0
Intra-operative recording prior to the incision and surgical procedure

Eligibility
Key inclusion criteria
• Age 18 – 75
• Sustained a single malleolar, bimalleolar or trimalleolar ankle fracture with or without syndesmotic injury (OTA/AO type 44 A, B or C) where surgery is indicated and will be performed with a single or dual incision.
• Isolated Injury

Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• • Planned surgery to involve tibial-talar-calcaneal hind foot nail, fibular nail or other percutaneous techniques without open reduction.
• Patients ineligible for an ankle nerve block (e.g. concern for compartment syndrome)
• Open injury
• Patients treated with external fixation
• Presence of peripheral neuropathy
• Presence of dementia of neurocognitive conditions
• Inability to consent
• Chronic opioid use or IV drug user
• History of opiate abuse
• Polytrauma as defined as additional bony injury, visceral injury or moderate soft tissue injury (requiring suture repair or other invasive procedure)
• Prisoners (unlikely to be accessible for follow-up)
• Pregnant patients
• Non-English-speaking subjects (post-operative data collection procedure involves conversations via phone calls. As we do not have access to translators for this research project, we will work exclusively with English-speaking subjects).
• Allergies or contraindications to local anaesthesia
• Medical comorbidities preventing general anaesthesia

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)
Once enrolled, participants will undergo randomisation to one of two treatments through a computer-generated algorithm. Investigators collecting outcome measures will be blinded to group allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once enrolled, participants will undergo randomisation to one of two treatments through a computer-generated algorithm
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary outcome will be assessed using repeated measures ANOVA. Secondary outcomes will be compared using a Wilcoxon Signed-rank test, and Chi-Square for comparison of group characteristics.

Sample size was determined based on a MCID of 1.6-1.9, powering for a mean difference of 2, with SD of 2, alpha 0.05, power 0.8 with a 12% drop out rate, based on previous literature. This gave a a required sample size of 20 in each group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 26569 0
New Zealand
State/province [1] 26569 0
Northland

Funding & Sponsors
Funding source category [1] 317459 0
Self funded/Unfunded
Name [1] 317459 0
Country [1] 317459 0
Primary sponsor type
Hospital
Name
Whangarei Hospital
Address
Country
New Zealand
Secondary sponsor category [1] 319748 0
None
Name [1] 319748 0
none
Address [1] 319748 0
Country [1] 319748 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316174 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 316174 0
Ethics committee country [1] 316174 0
New Zealand
Date submitted for ethics approval [1] 316174 0
30/10/2024
Approval date [1] 316174 0
Ethics approval number [1] 316174 0

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

Contacts
Principal investigator
Name 137030 0
Dr Wayne Hoskins
Address 137030 0
Whangarei Hospital, Private Bag 9742 Maunu Rd, Whangarei 0148
Country 137030 0
New Zealand
Phone 137030 0
+64 273134583
Fax 137030 0
Email 137030 0
[email protected]
Contact person for public queries
Name 137031 0
Wayne Hoskins
Address 137031 0
Whangarei Hospital, Private Bag 9742 Maunu Rd, Whangarei 0148
Country 137031 0
New Zealand
Phone 137031 0
+64 273134583
Fax 137031 0
Email 137031 0
[email protected]
Contact person for scientific queries
Name 137032 0
Wayne Hoskins
Address 137032 0
Whangarei Hospital, Private Bag 9742 Maunu Rd, Whangarei 0148
Country 137032 0
New Zealand
Phone 137032 0
+64 273134583
Fax 137032 0
Email 137032 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
Data will not be shared


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.