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

NCT07131657 | Completed Phase 2

• 1 other identifier: PF_002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Upper Extremity Surgery; Nerve Block

Keywords

ropivacaine; clonidine; betamethasone; supraclavicular brachial nerve block

Outcome Measures

Primary Outcomes (2)

• Duration of analgesia

  From end of Ropiclobet injection to the first sensation of pain at surgical site (minutes/hours), up to 48 hours

• Number of treatment-related adverse events assessed by NCI-CTCAE

  From the beginning of the nerve block procedure to the end of study visit at 30 days

Secondary Outcomes (9)

• Pain at rest

  pre-block, and 0, 2, 4, 6, 12, 18, 24 and 48 hours post-block, on Day 15 and 30.

• Pain during movement

  pre-block, and 0, 2, 4, 6, 12, 18, 24 and 48 hours post-block, on Day 15 and 30

• Onset time of motor block

  Pre-block, and at 5, 10, 15, 20, 25, 30 minutes, as well as 6, 12, 24 and 48 hours post-injection.

• Duration of motor block

  From nerve block procedure to the resolution of the motor block, up to 48 hours

• Onset time of sensory block

  Pre-block, and at 5, 10, 15, 20, 25, 30 minutes, as well as 6, 12, 24 and 48 hours post-injection.

Study Arms (1)

Nerve block arm

EXPERIMENTAL

Volunteers will undergo supraclavicular brachial nerve block preoperatively using the combination drug Ropiclobet (Ropivacaine-Clonidine-Betamethasone)

Drug: Ropivacaine + Clonidine + Betamethasone

Interventions

Ropivacaine + Clonidine + Betamethasone DRUG

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

Nerve block arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients with age of ≥18 years and ≤ 65 years at the time of consent.
• Ability and willingness to provide informed consent or consent from their legal representative and willingness to comply with all planned visits and study procedures.
• American Society of Anesthesiologists (ASA) physical status class of I-III
• BMI ≤ 30 kg/m2
• An ECG within normal values or clinically insignificant findings.
• Patients undergoing upper extremity procedures suitable for SCB anesthesia, including arm, elbow, forearm, and hand surgeries.
• Emergency and/or elective surgeries
• Women of childbearing potential (WOCBP) must have a negative urine pregnancy testing at screening visit.

You may not qualify if:

• An inability to cooperate during the block placement.
• Patients undergoing shoulder procedures.
• History of allergy to active ingredients (including their derivatives) of the study medication.
• History of allergy to analgesics (e.g. acetaminophen, non-steroidal anti-inflammatory medications, oral opioid analgesics)
• History of shoulder or clavicular surgery.
• Known bronchopulmonary or phrenic pathology compromising respiratory function.
• Existing chronic pain disorders or history of use of ≥ 30mg oxycodone or equivalent per day
• Pre-existing neurological deficits or peripheral neuropathy involving the operative upper extremity
• Infection at the puncture site for the block.
• History of coagulopathy disorders and/or bleeding diathesis.
• Pregnant or breastfeeding.
• History of any documented medical condition considered to be clinically significant and could potentially affect patient safety or study outcome, in the opinion of the investigator: uncontrolled diabetes, uncontrolled hypertension, cardiovascular diseases, acute or chronic kidney diseases, liver diseases, psychiatric disorders, malignancy, systemic infection.
• Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or might influence the results of the study, or the patient's ability to complete the entire duration of the study.
• Participation in a clinical trial involving current or another investigational product in the previous 3 months.
• Currently taking long-term systemic steroids (excluding inhaled medication for asthma treatment)

Sponsors & Collaborators

• PHARMAFINA: lead

Study Sites (1)

Istanbul Medeniyet University, Göztepe Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, 34722, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Ropivacaine; Clonidine; Betamethasone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 20, 2025
• Study Start: September 2, 2025
• Primary Completion: December 3, 2025
• Study Completion: December 9, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)