The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks

Launched by ZIEKENHUIS OOST-LIMBURG · Dec 15, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how different strengths of a medication called ropivacaine affect the speed and length of pain relief when used for ankle blocks during foot surgery, specifically for a condition known as hallux valgus (commonly known as a bunion). The goal is to find out whether using lower or higher concentrations of ropivacaine will provide quicker pain relief and longer-lasting effects after surgery. This study is important because it could help doctors use the right amount of medication, improving patient comfort while reducing the risk of side effects.

To join the trial, participants need to be between 18 and 75 years old and scheduled for elective foot surgery at a specific hospital. They should be in good health (classified as ASA physical I-II-III), able to walk on their own, and willing to perform some simple tests at home to assess their sensation after the surgery. However, people with certain conditions, such as allergies to local anesthetics or preexisting nerve problems, will not be eligible. Participants can expect to receive detailed information about the study procedures and will be supported throughout the process to ensure their safety and comfort.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Provide signed and dated informed consent
• • Age 18 to 75 years, scheduled for elective forefoot surgery for hallux valgus repair under unilateral ankle block at ZOL Genk
• • 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 perform these sensory and motor assessments by him/herself at home at postoperative day 0 to 2
• Exclusion Criteria:
• • 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