Phase I Study of Ropivacaine, Clonidine, and Betamethasone Combination for Sciatic Nerve Block in the Popliteal Region (RopiCloBet)

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…

• Number of treatment-related adverse events assessed by NCI-CTCAE
• Number of treatment-related adverse events assessed by laboratory parameters
• Number of treatment-related adverse events assessed by ECG
• Number of treatment-related adverse events assessed by physical examination and vital signs

1. Last registry update

   May 18, 2025

2. Study completion

   Apr 25, 2025

3. Primary completion

   Feb 20, 2025

4. Registered

   Jan 17, 2025

5. Started

   Nov 13, 2024