Study of different ropivacaine concentrations in ankle nerve block for hallux valgus (bunion) surgery patients

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What is this study about?

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.

1 Initial procedure

You will receive an ankle block (local anesthetic injection near the ankle) before the hallux valgus repair surgery (bunion correction).

The ankle block will be performed using ultrasound guidance with one of three different concentrations of ropivacaine (0.25%, 0.5%, or 1%).

The medical team will test your sensitivity to pinprick, cold, and light touch before the procedure.

2 Surgery and immediate post-operative period

The hallux valgus repair surgery will be performed while your foot is numb from the ankle block.

After the surgery, you will need to perform self-assessments of sensation and movement in your operated foot.

The medical team will monitor your pain levels and any pain medication usage.

3 Home monitoring – Days 0-2

You will need to perform regular self-assessments at home for the first 48 hours after surgery.

These assessments include testing sensitivity to pinprick, cold, and light touch in your operated foot.

You will need to record your pain levels and any pain medication taken during this period.

The ability to move your foot will also need to be assessed and recorded.

4 Follow-up assessment

The medical team will evaluate how long the ankle block lasted.

Your pain management and movement recovery will be assessed.

The amount of pain medication used during the recovery period will be reviewed.

Who Can Join the Study?

  • 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

    These tests will need to be performed by the patient at home during the first 2 days after surgery

Who Cannot Join the Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Ziekenhuis Oost Limburg Genk Belgium

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
01.02.2024

Trial locations

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.

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 ID:
2024-510569-41-00
NCT ID:
NCT06185608
Trial Phase:
Therapeutic confirmatory (Phase III)

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