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

Phase 1
Conditions
Hallux valgus
Therapeutic area: Health Care [N] - Health Care Quality, Access, and Evaluation [N05]
Registration Number
CTIS2024-510569-41-00
Lead Sponsor
Ziekenhuis Oost Limburg
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
126
Inclusion Criteria

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

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 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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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