Hallux ValgusROADSNCT06185608
The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks
A study testing 0.25% ropivacaine, 0.5% ropivacaine and 1% ropivacaine in people with Hallux Valgus and Anesthesia, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hallux Valgus, Anesthesia
- What is being tested?
- 0.25% ropivacaine, 0.5% ropivacaine and 1% ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteBelgium
- Study dates
- 22 May 2025to 1 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Ingrid Meex, ZOL anesthesia study team, +3289325207, ingrid.meex@zol.be
About this study
Official title: The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ultrasound-guided Ankle Blocks in Patients Undergoing Hallux Valgus Repair Surgery - a Randomized, Double-blinded, Parallel-group Interventional Study
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.
Read the 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 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.
- Conditions
- Hallux Valgus, Anesthesia
- Being tested
- 0.25% ropivacaine, 0.5% ropivacaine, 1% ropivacaine
- Keywords
- Ropivacaine, Peripheral Nerve Block, Locoregional anesthesia, Onset, Duration, Sensory block
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% ropivacaineDrug
Also called Group 1
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% ropivacaineDrug
Also called Group 2
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% ropivacaineDrug
Also called Group 3
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 group | Role | What they receive |
|---|---|---|
| 0.25% ropivacaine group | Active comparator | This group will receive a total of 15 mL of 0.25% ropivacaine. Receives: Drug: 0.25% ropivacaine |
| 0.5% ropivacaine group | Active comparator | This group will receive a total of 15 mL of 0.5% ropivacaine. Receives: Drug: 0.5% ropivacaine |
| 1% ropivacaine group | Active comparator | This group will receive a total of 15 mL of 1% ropivacaine. Receives: Drug: 1% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration
The difference in sensory block duration across the different groups.
Measured: 48 hours
Secondary outcomes (5)
Onset
The difference in sensory block onset across the different groups.
Measured: 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.
Measured: 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.
Measured: 48 hours
Opioid consumption
The difference in opioid consumption across the different groups.
Measured: 48 hours
Proportion failed blocks
The difference in the proportion of failed blocks across the different groups.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start22 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imré Van Herreweghe, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185608
- Sponsor's protocol ID
- ROADS
- Acronym
- ROADS
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No