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

NCT06185608 | Recruiting

• 1 other identifier: ROADS
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hallux Valgus; Anesthesia

Keywords

Ropivacaine; Peripheral Nerve Block; Locoregional anesthesia; Onset; Duration; Sensory block

Outcome Measures

Primary Outcomes (1)

• Duration

  The difference in sensory block duration across the different groups.

  48 hours

Secondary Outcomes (5)

• Onset

  30 minutes

• Motor function

  48 hours

• Pain scores

  48 hours

• Opioid consumption

  48 hours

• Proportion failed blocks

  48 hours

Study Arms (3)

0.25% ropivacaine group

ACTIVE COMPARATOR

This group will receive a total of 15 mL of 0.25% ropivacaine.

Drug: 0.25% ropivacaine

0.5% ropivacaine group

ACTIVE COMPARATOR

This group will receive a total of 15 mL of 0.5% ropivacaine.

Drug: 0.5% ropivacaine

1% ropivacaine group

ACTIVE COMPARATOR

This group will receive a total of 15 mL of 1% ropivacaine.

Drug: 1% ropivacaine

Interventions

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.

Also known as: Group 1

0.25% ropivacaine group

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.

Also known as: Group 2

0.5% ropivacaine group

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.

Also known as: Group 3

1% ropivacaine group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

MeSH Terms

Conditions

Hallux Valgus

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Imré Van Herreweghe, MD

CONTACT

+32474661273; imrevanherreweghe@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Staff performing perineural blocks will not be blinded to the concentration of ropivacaine that will be administered. However, patients, and research personnel collecting postoperative data will be blinded to group allocation. The clinical anesthesiologist in the operating theatre is blinded to the concentration of ropivacaine administered as this is not the same practitioner as the one performing the ankle block.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: May 22, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

BE (1)