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

Anesthesia Clinical Trial

— ROADS  

Official title:

The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Block - a Randomized, Triple-blinded, Parallel-group Interventional Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06185608
• Other study ID #: ROADS
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: August 1, 2026

Study information

• Verified date: December 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: Imré Van Herreweghe, MD
• Phone: +32474661273
• Email: imrevanherreweghe[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Peripheral nerve blocks are essential in ensuring effective regional anesthesia and postoperative analgesia in forefoot surgery for hallux valgus repair. 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.

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, the postoperative pain scores, and the opioid consumption.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: August 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Provide signed and dated informed consent
• Age 18 to 65 years, scheduled for elective forefoot surgery for hallux valgus repair under unilateral ankle block at ZOL Genk
• ASA physical I-II-III
• Able to understand the researchers
• 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

Related Conditions & MeSH terms

• Anesthesia
• Hallux Valgus

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration	The difference in sensory block duration across the different groups.	48 hours
Secondary	Onset	The difference in sensory block onset across the different groups.	30 minutes
Secondary	Pain scores	The difference in postoperative pain scores across the different groups.	72 hours
Secondary	Opioid consumption	The difference in opioid consumption across the different groups.	One week