Phase 2Completed
Ropiclobet for Regional Anesthesia and Post-Operative Pain Control in Upper Extremity Surgery
A Phase II, Single Arm, Open-label, Three-dose Group Study to Evaluate the Efficacy and Safety of Ropivacaine-betamethasone-clonidine (Ropiclobet) Injectable Solution for Regional Anesthesia and Post-operative Pain Control in Patients Undergoing Upper Extremity Surgery Below Shoulder
- Sponsor
- PHARMAFINA (Industry)
- Enrollment
- 40 enrolled
- Conditions
- Nerve Block; Upper Extremity Surgery
- Interventions
- Ropivacaine + Clonidine + Betamethasone; Ropivacaine + Clonidine + Betamethasone; Ropivacaine + Clonidine + Betamethasone
- Ages
- adults, older adults
- Registry
- NCT07131657
Full record on ClinicalTrials.gov
From the registry
This is a national, single-center, single-arm, open-label Phase II clinical trial designed to evaluate the efficacy and safety of Ropiclobet, a fixed-dose injectable solution containing Ropivacaine HCl, Betamethasone Sodium Phosphate, and Clonidine HCl. The study includes three non-randomized dose groups and will enroll a total of 60 adult volunteers undergoing upper extremity surgery (arm, elbow, forearm, or hand). All participants will receive a single administration of Ropiclobet via supraclavicular brachial plexus block (SCB) under ultrasound guidance. Sedation may be provided if necessary; however, participants requiring general anesthesia will be excluded from the study. Postoperatively, volunteers will be monitored in the PACU for 2 hours, followed by transfer to a regular hospital ward under anesthesiology supervision. All participants will remain under clinical observation for 48 hours following the procedure. If the sensory or motor block persists beyond this period, monitoring will continue until full resolution and an additional 6 hours of observation will be provided.…
Primary outcomes
- Duration of analgesia
- Number of treatment-related adverse events assessed by NCI-CTCAE
History
Last registry update
Study completion
Primary completion
Started
Registered