Ziekenhuis Oost Limburg
Genk, Belgium
RecruitingFoot deformity
Study of different ropivacaine concentrations in ankle nerve block for hallux valgus (bunion) surgery patients
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial focuses on patients undergoing surgery for hallux valgus, commonly known as a bunion, which is a foot deformity where the big toe points toward the other toes. The study examines the use of ropivacaine, a local anesthetic medication that blocks pain signals, administered through an ankle block procedure where the medication is injected around the nerves of the ankle.
The purpose of this research is to compare how different strengths of ropivacaine (0.25%, 0.5%, and 1%) affect the duration of pain relief after bunion surgery. The medication will be given before the surgery using ultrasound guidance to ensure accurate placement. Patients will receive one of these three different concentrations of the medication.
During the study, which lasts 48 hours after surgery, the medical team will monitor how long the pain-blocking effects last, how quickly the medication starts working, and how it affects leg movement. They will also track pain levels and the need for additional pain medication. The study uses specialized techniques to deliver the medication precisely to the nerves around the ankle to provide pain relief during and after the surgery.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
7 criteria
- Must provide written informed consent to participate in the study
- Must be between 18 and 75 years old and scheduled for planned foot surgery to correct hallux valgus (a condition where the big toe points toward the other toes) with ankle block
- Must have a physical health status of ASA I, II, or III (ASA is a scale used by doctors to assess a patient's health before surgery, where I means healthy, II means mild systemic disease, and III means severe systemic disease)
- Must be able to walk independently without using any walking aids (like crutches or walkers)
- Must be able to understand and perform study-related tests including:
- Response to pin pricks
- Ability to feel cold sensations
- Ability to feel light touch
Who cannot join the trial?
14 criteria
- Age below 18 or above 65 years
- Known allergy or hypersensitivity to ropivacaine (the local anesthetic used in the study)
- Infection at the site of planned ankle block injection
- History of peripheral neuropathy (nerve damage in feet or ankles)
- Blood clotting disorders or current use of blood thinning medications
- Inability to provide informed consent
- Significant cardiovascular disease (heart problems)
- Uncontrolled diabetes
- Current pregnancy or breastfeeding
- History of chronic pain requiring regular pain medication
- Previous foot surgery on the same foot
- Body Mass Index (BMI) greater than 35 (severe obesity)
- Active substance abuse or dependence
- Participation in another clinical trial within the past 30 days
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Investigated drugs
Ropivacaine is a local anesthetic medication used to block pain signals in specific areas of the body. In this trial, it is used to perform ankle blocks (a type of nerve block) in patients undergoing foot surgery. This medication works by temporarily numbing the nerves around the ankle area, preventing pain signals from reaching the brain. It belongs to the same family of medications as lidocaine but typically provides longer-lasting pain relief. Patients receiving this medication can remain awake during surgery while experiencing numbness in the targeted area.
What is already known about the treatment
Ropivacaine - A long-acting local anesthetic medication administered through injection for nerve blocks, particularly useful in surgical procedures and pain management. This medication works by blocking sodium channels in nerve cells, preventing the transmission of nerve impulses and thus creating temporary numbness in the targeted area. Ropivacaine belongs to the amino amide group of local anesthetics and is commonly used in regional anesthesia, offering a favorable safety profile with less cardiac and central nervous system toxicity compared to similar medications. The medication is particularly effective for peripheral nerve blocks, such as ankle blocks for foot surgery, with different concentrations (0.25%, 0.5%, and 1%) providing varying degrees of anesthetic effect and duration.
Investigated diseases
Hallux valgus - A common foot deformity where the big toe deviates toward the other toes, creating a bump on the inside edge of the foot. The condition develops gradually as the first metatarsal bone shifts outward while the big toe leans inward, causing the joint to become enlarged and prominent. This misalignment can lead to pain and discomfort while walking or wearing shoes. The condition may be accompanied by swelling around the affected joint and the development of calluses or corns where the foot rubs against footwear. Over time, the deformity can cause changes in walking patterns and pressure distribution across the foot.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510569-41-00Estimated enrolment174 patientsSponsorZiekenhuis Oost Limburg
sourced from the EU Clinical Trials Register and site verification
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