Authorised Therapeutic use (Phase IV) Hallux valgus

The effects of various concentrations of ropivacaine on the onset and duration of ultrasound-guided ankle blocks in patients undergoing hallux valgus repair surgery

EU CTIS ID: 2024-510569-41-00

What this study is testing

To compare the duration of the sensory block in patients having hallux valgus repair surgery under ankle block with 0.25%, 0.5%, and 1% ropivacaine over a 48-hour period.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Provide signed consent and dated informed consent
  • Age 18 up to and including 75 years, scheduled for elective forefoot surgery for hallux valgus repair under unilateral ankle block at ZOL Genk
  • American Society of Anesthesiologists (ASA) physical status I-II-III
  • Able to ambulate (ability to walk independently, without assistive devices)
  • Able to learn and perform study sensory and motor assessment by exhibiting sensitivity to pinprick, cold, and light touch (tested beforehand with pinprick, cold, light touch sensation test) as the patient will have to perform these sensory and motor assessments by themselves at home at postoperative days 0 to 2

You likely can't join if

  • Language barrier
  • Preexisting lower extremity neuropathy
  • Contraindications to ankle block (local infection, edema, burn, soft tissue trauma, or distorted anatomy with scarring in the area of block placement)
  • Contraindications for use of non-steroidal anti-inflammatory drugs (NSAIDs)
  • Allergy to local anesthetics
  • Uncontrolled anxiety, psychiatric or neurological disorder that might interfere with study assessment
See the full eligibility criteria
Who can join
  • Provide signed consent and dated informed consent
  • Age 18 up to and including 75 years, scheduled for elective forefoot surgery for hallux valgus repair under unilateral ankle block at ZOL Genk
  • American Society of Anesthesiologists (ASA) physical status I-II-III
  • Able to ambulate (ability to walk independently, without assistive devices)
  • Able to learn and perform study sensory and motor assessment by exhibiting sensitivity to pinprick, cold, and light touch (tested beforehand with pinprick, cold, light touch sensation test) as the patient will have to perform these sensory and motor assessments by themselves at home at postoperative days 0 to 2
What rules you out
  • Language barrier
  • Preexisting lower extremity neuropathy
  • Contraindications to ankle block (local infection, edema, burn, soft tissue trauma, or distorted anatomy with scarring in the area of block placement)
  • Contraindications for use of non-steroidal anti-inflammatory drugs (NSAIDs)
  • Allergy to local anesthetics
  • Uncontrolled anxiety, psychiatric or neurological disorder that might interfere with study assessment
  • Weight below 50 kg (based on a maximum dose of 3 mg/kg ropivacaine and a maximum dose of 150 mg ropivacaine)
  • Preoperative use of opioids or gabapentin less than 3 days before surgery

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.