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Clinical Trials in Belgium / NCT06185608
Recruiting Not applicable

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

NCT06185608 · tracked via the Priya Life Science Belgium tracker
Sponsor
Ziekenhuis Oost-Limburg
Phase
Not applicable
Started
2025-05-22
Last updated
2026-03-24

Condition(s) studied

Hallux ValgusAnesthesia

Investigational drug(s) / intervention(s)

0.25% ropivacaine →0.5% ropivacaine →1% ropivacaine →

0.25% ropivacaine: A total of 15 ml of 0.25% ropivacaine will be administered and distributed strategically among the specific nerves: 6 ml for the tibial nerve, 3 ml for the deep peroneal nerve, and 2 ml each for the superficial peroneal nerve, saphenous nerve, and sural nerve.

0.5% ropivacaine: A total of 15 ml of 0.5% ropivacaine will be administered and distributed strategically among the specific nerves: 6 ml for the tibial nerve, 3 ml for the deep peroneal nerve, and 2 ml each for the superficial peroneal nerve, saphenous nerve, and sural nerve.

1% ropivacaine: A total of 15 ml of 1% ropivacaine will be administered and distributed strategically among the specific nerves: 6 ml for the tibial nerve, 3 ml for the deep peroneal nerve, and 2 ml each for the superficial peroneal nerve, saphenous nerve, and sural nerve.

Study summary

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. In the advent of ultrasound-guided nerve blocks, the accuracy in administering LA has significantly improved, potentially reducing the required dosage, which is also associated with less risk for toxicity. However, the effect of the concentration of LA on the onset time and duration of ultrasound-guided ankle blocks for forefoot surgery has not yet been studied. This poses a clinically relevant dilemma regarding the necessity of administering lower or higher concentrations of ropivacaine to achieve a clinically relevant faster onset time and longer duration of an ankle block.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion 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 procedures, 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ziekenhuis Oost-Limburg Genk Limburg Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06185608 on ClinicalTrials.gov ↗ ← All trials in Belgium