Hallux Valgus, Anesthesia
Conditions
Keywords
Ropivacaine, Peripheral Nerve Block, Locoregional anesthesia, Onset, Duration, Sensory block
Brief summary
Peripheral nerve blocks are essential in ensuring effective regional anesthesia and postoperative analgesia in forefoot surgery for hallux valgus repair, with or without minor concomitant toe procedures. 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.
Interventions
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.
DRUG0.5% 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.
DRUG1% 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.
Sponsors
Ziekenhuis Oost-Limburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Staff performing perineural blocks will not be blinded to the concentration of ropivacaine that will be administered. However, patients, and research personnel collecting postoperative data will be blinded to group allocation. The clinical anesthesiologist in the operating theatre is blinded to the concentration of ropivacaine administered as this is not the same practitioner as the one performing the ankle block.
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration | 48 hours | The difference in sensory block duration across the different groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset | 30 minutes | The difference in sensory block onset across the different groups. |
| Motor function | 48 hours | The difference in motor function across the different groups. The motor function will be evaluated with NRS during movement and at rest. The following scale will be used: 0 full strength, 1 ability to move but weakness experienced, 2 unable to move and no strength. |
| Pain scores | 48 hours | The difference in postoperative pain scores across the different groups using a numeric rating scale from 0 being 'no pain' to 10 being 'worst pain imaginable'. The highest score (10) correlates with severe pain and thus worse outcome. |
| Opioid consumption | 48 hours | The difference in opioid consumption across the different groups. |
| Proportion failed blocks | 48 hours | The difference in the proportion of failed blocks across the different groups. |
Countries
Belgium
Contacts
CONTACTImré Van Herreweghe, MD
Outcome results
None listed