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

NCT ID: NCT06185608

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-22
• Study Completion Date: 2027-10-01

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

0.25% ropivacaine group

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

Group Type: ACTIVE_COMPARATOR

0.25% ropivacaine

Intervention Type: 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.

0.5% ropivacaine group

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

Group Type: ACTIVE_COMPARATOR

0.5% ropivacaine

Intervention Type: 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.

1% ropivacaine group

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

Group Type: ACTIVE_COMPARATOR

1% ropivacaine

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Group 1; Group 2; Group 3

Eligibility Criteria

Inclusion Criteria

• Provide signed and dated informed consent
• Age 18 to 75 years, scheduled for elective forefoot surgery for hallux valgus repair 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: lead

Responsible Party

Imré Van Herreweghe

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Imré Van Herreweghe, MD

Role: CONTACT

imrevanherreweghe@gmail.com

+32474661273

Facility Contacts

Ingrid Meex, ZOL anesthesia study team

Role: primary

ingrid.meex@zol.be

+3289325207

Other Identifiers

ROADS

Identifier Type: -

Identifier Source: org_study_id