Effects of different concentrations of ropivacaine on ankle blocks for foot surgery

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

This study tests whether using different strengths of ropivacaine for ankle blocks can help people having foot surgery feel less pain and recover faster.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 174 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Ziekenhuis Oost-Limburg (other)
• Locations: 1 site (Genk, Limburg)
• Trial ID: NCT06185608 on ClinicalTrials.gov

What this trial studies

This study evaluates how varying concentrations of ropivacaine (0.25%, 0.5%, and 1%) affect the onset time and duration of ultrasound-guided ankle blocks in patients undergoing forefoot surgery for hallux valgus repair. The research aims to determine whether higher concentrations lead to faster onset and longer sensory block duration, which could improve postoperative analgesia. Primary outcomes include the duration of sensory blocks, while secondary outcomes assess onset time, motor function, pain scores, opioid consumption, and block failure rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 scheduled for elective forefoot surgery for hallux valgus repair who can provide informed consent and perform sensory assessments.

Not a fit: Patients with preexisting lower extremity neuropathy, contraindications to ankle block, or allergies to local anesthetics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance pain management strategies for patients undergoing forefoot surgery, leading to improved recovery experiences.

How similar studies have performed: While the effects of ropivacaine concentrations have been studied in other contexts, this specific evaluation of ultrasound-guided ankle blocks is novel.

Eligibility criteria

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

Where this trial is running

Genk, Limburg

• Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (RECRUITING)

Study contacts

• Study coordinator: Imré Van Herreweghe, MD

Conditions: Hallux Valgus, Anesthesia, Ropivacaine, Peripheral Nerve Block, Locoregional anesthesia, Onset, Duration, Sensory block