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NCT Number: NCT06185608

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

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.

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Key information

Conditions

Hallux Valgus Anesthesia Foot Deformities Musculoskeletal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location status: Recruiting

Location contact

Ingrid Meex, ZOL anesthesia study team

CONTACT

[email protected]

+3289325207

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.25% ropivacaine

Drug

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.

Other names: Group 1

0.5% ropivacaine

Drug

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.

Other names: Group 2

1% ropivacaine

Drug

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.

Other names: Group 3

Primary outcomes

  1. Duration

    Time frame: 48 hours

    The difference in sensory block duration across the different groups.

Secondary outcomes

  1. Onset

    Time frame: 30 minutes

    The difference in sensory block onset across the different groups.

  2. Motor function

    Time frame: 48 hours

    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.

  3. Pain scores

    Time frame: 48 hours

    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.

  4. Opioid consumption

    Time frame: 48 hours

    The difference in opioid consumption across the different groups.

  5. Proportion failed blocks

    Time frame: 48 hours

    The difference in the proportion of failed blocks across the different groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Imré Van Herreweghe, MD

CONTACT

[email protected]

+32474661273

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Official study 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

Acronym: ROADS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 29, 2023
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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