Status:
RECRUITING
The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks
Lead Sponsor:
Ziekenhuis Oost-Limburg
Conditions:
Hallux Valgus
Anesthesia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Peripheral nerve blocks are essential in ensuring effective regional anesthesia and postoperative analgesia in forefoot surgery for hallux valgus repair. Many factors influence the onset and duration ...
Detailed Description
This study aims to evaluate the differential effects of 0.25%, 0.5%, and 1% ropivacaine on the onset time and duration of ultrasound-guided ankle blocks in patients having forefoot surgery for anesthe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT06185608
Start Date
May 22 2025
End Date
October 1 2027
Last Update
May 25 2025
Active Locations (1)
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1
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600