Clinical trial NCT06185608: The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hallux Valgus
Anesthesia
Keywords: Ropivacaine
Peripheral Nerve Block
Locoregional anesthesia
Onset
Duration
Sensory block
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Duration
timeFrame: 48 hours
Secondary outcomes:
measure: Onset
timeFrame: 30 minutes
measure: Motor function
timeFrame: 48 hours
measure: Pain scores
timeFrame: 48 hours
measure: Opioid consumption
timeFrame: 48 hours
measure: Proportion failed blocks
timeFrame: 48 hours
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References: