A Prospective, Non-Inferiority Randomised Trial Evaluating Regional Anaesthesia and Ankle Block for Acute Pain Control of Operatively Treated Ankle Fractures

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624001237572

Acronym

APPLE: Ankle fracture Postoperative Pain Local Anaesthetic

Enrollment

Registered

2024-10-09

Start date

2025-09-18

Completion date

2025-12-31

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We hypothesise that patient receiving an ankle block the same improved postoperative pain control compared to those receiving regional anaesthesia (popliteal and saphenous block). We will compare these two interventions in patients undergoing surgical fixation of ankle fractures in a randomised controlled trial. This will help determine the best form of pain control for patients in the future.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

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

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

Outcome results