Ropiclobet for Regional Anesthesia and Post-Operative Pain Control in Upper Extremity Surgery (NCT07131657) | Clinical Trial Compass
CompletedPhase 2
Ropiclobet for Regional Anesthesia and Post-Operative Pain Control in Upper Extremity Surgery
Turkey (Türkiye)40 participantsStarted 2025-09-02
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Pregnan…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of analgesia
Timeframe: From end of Ropiclobet injection to the first sensation of pain at surgical site (minutes/hours), up to 48 hours
2
Number of treatment-related adverse events assessed by NCI-CTCAE
Timeframe: From the beginning of the nerve block procedure to the end of study visit at 30 days