An interventional study of 0.25% ropivacaine and 0.5% ropivacaine in Hallux Valgus and Anesthesia, sponsored by Ziekenhuis Oost-Limburg. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Ziekenhuis Oost-Limburg · Not applicable, Interventional, and Treatment
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.
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 anesthesia and postoperative analgesia. We hypothesize that the use of 1% ropivacaine for ultrasound guided ankle blocks will result in a significantly faster onset time and a longer sensory block duration, and thus analgesia, compared to the use of 0.25% and 0.5% ropivacaine in patients having forefoot surgery. The primary outcome is the difference in the duration of the sensory blocks. The secondary outcomes are the difference in onset time of the sensory block, motor function, the postoperative pain scores, opioid consumption, and proportion of failed blocks.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
This study's planned enrollment of 174 is above the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Browse Hallux Valgus studies →Ziekenhuis Oost-Limburg is the lead sponsor of 69 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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This group will receive a total of 15 mL of 0.25% ropivacaine.
Drug: 0.25% ropivacaine
This group will receive a total of 15 mL of 0.5% ropivacaine.
Drug: 0.5% ropivacaine
This group will receive a total of 15 mL of 1% ropivacaine.
Drug: 1% 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.
Also known as: Group 1
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.
Also known as: Group 2
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.
Also known as: Group 3
Duration
The difference in sensory block duration across the different groups.
Time frame: 48 hours
Onset
The difference in sensory block onset across the different groups.
Time frame: 30 minutes
Motor function
The difference in motor function across the different groups. The motor function will be evaluated with NRS during movement and at rest. The following scale will be used: 0 full strength, 1 ability to move but weakness experienced, 2 unable to move and no strength.
Time frame: 48 hours
Pain scores
The difference in postoperative pain scores across the different groups using a numeric rating scale from 0 being 'no pain' to 10 being 'worst pain imaginable'. The highest score (10) correlates with severe pain and thus worse outcome.
Time frame: 48 hours
Opioid consumption
The difference in opioid consumption across the different groups.
Time frame: 48 hours
Proportion failed blocks
The difference in the proportion of failed blocks across the different groups.
Time frame: 48 hours
Started May 2025 (actual). Primary completion is estimated for May 2027, 23 months after the start.
Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's planned 23 months is close to that.
Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ropivacaine
Ziekenhuis Oost-Limburg