This is a national, single-center, dose-escalation Phase I study to investigate the safety, pharmacokinetics, and efficacy of a combination containing Ropivacaine, Clonidine, and Betamethasone (Ropiclobet) in healty volunteers. After screening and eligibility confirmation, at least 28 participants will receive a sciatic nerve block in the popliteal region with Ropiclobet, followed by pharmacokinetic assessments through blood sampling and monitoring of motor and sensory nerve blocks in the tibial and common peroneal nerves. Safety evaluations, including physical exams, vital signs, ECGs, and sedation scores, will be conducted throughout the study. sensory blocks resolve. Participants will remain under observation for 48 hours post-procedure and will be discharged once motor and sensory blocks resolve. Follow-up visits will be conducted on Days 10 and 15 on an outpatient basis, with an end-of-study visit planned for Day 30. The dose-escalation protocol involves administering 5 mL, 10 mL, 15 mL, and 20 mL doses to sequential groups of participants, with safety assessments performed after each dose level before proceeding.
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Number of treatment-related adverse events assessed by NCI-CTCAE
Timeframe: From nerve block procedure to the end of study visit at 30 days
Number of treatment-related adverse events assessed by laboratory parameters
Timeframe: Before nerve block procedure, 24 and 48 hours after procedure, and during follow-up visits on Day 10, Day 15, Day 30
Number of treatment-related adverse events assessed by ECG
Timeframe: From nerve block procedure to discharge at 48 hours, and during follow-up visits on Day 10, Day 15, Day 30
Number of treatment-related adverse events assessed by physical examination and vital signs
Timeframe: From nerve block procedure to discharge at 48 hours, and during follow-up visits on Day 10, Day 15, Day 30