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

The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Block - a Randomized, Triple-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. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia; Hallux Valgus
• Intervention / Treatment: Drug: 0.25% ropivacaine; Drug: 0.5% ropivacaine; Drug: 1% ropivacaine

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, the postoperative pain scores, and the opioid consumption.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Imré Van Herreweghe, MD; Phone Number: +32474661273; Email: imrevanherreweghe@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.25% ropivacaine group; This group will receive a total of 15 mL of 0.25% ropivacaine.	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.
Active Comparator: 0.5% ropivacaine group; This group will receive a total of 15 mL of 0.5% ropivacaine.	Drug: 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.
Experimental: 1% ropivacaine group; This group will receive a total of 15 mL of 1% ropivacaine.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration	The difference in sensory block duration across the different groups.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset	The difference in sensory block onset across the different groups.	30 minutes
Pain scores	The difference in postoperative pain scores across the different groups.	72 hours
Opioid consumption	The difference in opioid consumption across the different groups.	One week

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Ropivacaine; Duration; Sensory block; Peripheral Nerve Block; Locoregional anesthesia; Onset
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hallux Valgus; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: ROADS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No