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New treatment option for Hallux Valgus
Official title The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks
ClinicalTrials.gov ID: NCT06185608
What this study is testing
What is 0.25% ropivacaine?
0.25% ropivacaine is an investigational medicine, being studied as a potential treatment for hallux valgus.
Also referred to as Group 1.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Peripheral nerve blocks are essential in ensuring effective regional anesthesia and postoperative analgesia in forefoot surgery for hallux valgus repair, with or without minor concomitant toe procedures. Many factors influence the onset and duration of peripheral nerve blocks.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Provide signed and dated informed consent
- Age 18 up to and including 75 years, scheduled for elective forefoot surgery for hallux valgus repair, with or without one or more of the following...
- ASA physical I-II-III
- Able to ambulate (ability to walk independently, with or 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...
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 NSAIDs
- Allergy to local anesthetics
- Uncontrolled anxiety, psychiatric or neurological disorder that might interfere with study assessment
See the full eligibility criteria
- Provide signed and dated informed consent
- Age 18 up to and including 75 years, scheduled for elective forefoot surgery for hallux valgus repair, with or without one or more of the following: minor toe procedures, osteotomies, arthrodesis or toe extensor/flexor...
- ASA physical I-II-III
- Able to ambulate (ability to walk independently, with or 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...
- 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 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
- Contraindications for use of paracetamol
- Contraindications for use of tramadol
The study team makes the final eligibility decision.
Where it's taking place
- Genk, Limburg, Belgium
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 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Genk, Limburg, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.