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Ropiclobet for Regional Anesthesia and Post-Operative Pain Control in Upper Extremity Surgery

NCT07131657 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-12

No results posted yet for this study

Summary

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. Follow-up visits are scheduled for Day 15 and Day 30 post-procedure.

The primary efficacy endpoint is the duration of analgesia and the primary safety endpoint is the incidence and characterization of all adverse events occurring during the procedure and within 30 days postoperatively.

Conditions

  • Nerve Block
  • Upper Extremity Surgery

Interventions

DRUG

Ropivacaine + Clonidine + Betamethasone

Ropivacaine HCl - Betamethasone Sodium Phosphate - Clonidine HCl 5.0/0.4\*/0.015 mg/mL (The solution contains 0.53 mg of betamethasone sodium phosphate, equivalent to 0.4 mg of betamethasone) Group I: A total of 20 mL will be injected: 10 mL Ropiclobet (1 ampoule) + 10 mL of 0.9% isotonic saline

DRUG

Ropivacaine + Clonidine + Betamethasone

Ropivacaine HCl - Betamethasone Sodium Phosphate - Clonidine HCl 5.0/0.4\*/0.015 mg/mL (The solution contains 0.53 mg of betamethasone sodium phosphate, equivalent to 0.4 mg of betamethasone) Group II: A total of 20 mL will be injected: 15 mL Ropiclobet (1.5 ampoules) + 5 mL of 0.9% isotonic saline

DRUG

Ropivacaine + Clonidine + Betamethasone

Ropivacaine HCl - Betamethasone Sodium Phosphate - Clonidine HCl 5.0/0.4\*/0.015 mg/mL (The solution contains 0.53 mg of betamethasone sodium phosphate, equivalent to 0.4 mg of betamethasone) Group III: A total of 20 mL will be injected: 20 mL Ropiclobet (2 ampoules)

Sponsors & Collaborators

  • PHARMAFINA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-02
Primary Completion
2025-12-03
Completion
2025-12-09

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07131657 on ClinicalTrials.gov