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

Launched by PHARMAFINA · Aug 12, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medicine called Ropiclobet to help control pain after surgery on the arm, elbow, forearm, or hand. Ropiclobet is given as a single injection near the nerves in the shoulder area to numb the arm during and after surgery. The goal is to see how well this medicine works to reduce pain and how safe it is for patients. The study will include 60 adults who are having upper arm surgeries and meet certain health requirements.

If you join the study, you’ll receive the Ropiclobet injection guided by ultrasound before your surgery. You may get light sedation if needed, but general anesthesia (being fully asleep) is not allowed in this study. After surgery, you’ll be watched closely for 48 hours to make sure the numbness goes away safely, with follow-up visits planned for 15 and 30 days later. To be eligible, you need to be an adult between 18 and 65 years old, in generally good health, and having certain types of arm surgery (but not shoulder surgery). You shouldn’t have allergies to the medicine, certain health problems, or be pregnant or breastfeeding. This study aims to find out if Ropiclobet can provide longer pain relief with few side effects after upper extremity surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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)