The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZiekenhuis Oost-Limburg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
0.25% ropivacaine
DrugA 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
DrugA 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
DrugA 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.
Treatment groups
174 Participants
are divided into 3 treatment groupsGroup A: 0.25% ropivacaine groupActive comparator 1 intervention
Group B: 0.5% ropivacaine groupActive comparator 1 intervention
Group C: 1% ropivacaine groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Duration
The difference in sensory block duration across the different groups.
Time frame
48 hoursSecondary outcomes
1
Onset
The difference in sensory block onset across the different groups.
Time frame
30 minutes2
Motor function
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.
Time frame
48 hours3
Pain scores
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.
Time frame
48 hours4
Opioid consumption
The difference in opioid consumption across the different groups.
Time frame
48 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov