Nerve BlockPhase 2NCT07131657
Ropiclobet for Regional Anesthesia and Post-Operative Pain Control in Upper Extremity Surgery
A Phase 2 study testing Ropivacaine + Clonidine + Betamethasone in people with Nerve Block and Upper Extremity Surgery, run by PHARMAFINA at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nerve Block, Upper Extremity Surgery
- What is being tested?
- Ropivacaine + Clonidine + Betamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2025to 9 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University, Göztepe Prof. Dr. Süleyman Yalçın City Hospital
Istanbul, 34722
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
This national, single-center, single-arm, open-label Phase II clinical trial includes three dose groups and aims to evaluate the efficacy and safety of Ropiclobet. Ropiclobet Injectable Solution is a fixed-dose combination containing Ropivacaine HCl, Betamethasone Sodium Phosphate, and Clonidine HCl at concentrations of 5.0/0.4*/0.015 mg/mL (*the 10 mL ampoule contains 0.53 mg of betamethasone sodium phosphate, equivalent to 0.4 mg of betamethasone).
A total of 60 volunteers (Hospitalized patients in the orthopedic department or outpatients who are scheduled for surgery) undergoing upper extremity surgery (including arm, elbow, forearm, and hand surgeries) will receive a single administration of the Ropiclobet combination via supraclavicular brachial nerve blockade (SCB) under ultrasound guidance.
The study will include three dose groups:
- Group I: 10 mL Ropiclobet combination (1 ampoule) diluted with 10 mL of 0.9% isotonic saline
- Group II: 15 mL Ropiclobet combination (1.5 ampoules) diluted with 5 mL of 0.9% isotonic saline
- Group III: 20 mL Ropiclobet combination (2 ampoules), administered undiluted. There will be no randomization for dose groups. The first 20 participants will be assigned to Group I. The study team will assess safety and efficacy parameters in these participants. Following the completion of 20 participants in Group I, the study will proceed to Group II. Group III will follow in the same manner, with 20 participants planned per group.
Ropiclobet injection will be performed preoperatively under sterile conditions by an experienced anesthesiologist. Only sedation may be administered if needed, and volunteers requiring general anesthesia will be withdrawn from the study.
Standard monitoring will include ECG, non-invasive blood pressure measurement, and pulse oximetry. Postoperatively, volunteers will be monitored in the PACU for 2 hours, followed by observation in the hospital ward under an anesthesiologist's supervision. Volunteers will remain under clinical observation for 48 hours post-procedure. If motor or sensory blockade persists beyond this period, monitoring will continue until full resolution plus an additional 6 hours. Follow-up visits will be at Day 15 and Day 30.
- Conditions
- Nerve Block, Upper Extremity Surgery
- Being tested
- Ropivacaine + Clonidine + Betamethasone
- Keywords
- ropivacaine, clonidine, betamethasone, supraclavicular brachial nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine + Clonidine + BetamethasoneDrug
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
Ropivacaine + Clonidine + BetamethasoneDrug
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
Ropivacaine + Clonidine + BetamethasoneDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Nerve block arm | Experimental | Volunteers will undergo supraclavicular brachial nerve block preoperatively using the combination drug Ropiclobet (Ropivacaine-Clonidine-Betamethasone) Receives: Drug: Ropivacaine + Clonidine + Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
Measured: 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
Measured: From the beginning of the nerve block procedure to the end of study visit at 30 days
Secondary outcomes (9)
Pain at rest
Assessment of pain at rest using the Visual Analog Scale (VAS), 0-10 scale (0 (no pain) to 10 (worst possible pain))
Measured: pre-block, and 0, 2, 4, 6, 12, 18, 24 and 48 hours post-block, on Day 15 and 30.
Pain during movement
Assessment of pain during movement of the surgical site using Visual Analog Scale (VAS), 0-10 scale (0 (no pain) to 10 (worst possible pain))
Measured: 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
Onset time of motor block is defined as the time (hour/minutes) from the completion of Ropiclobet injection to the onset of motor block. This will be assessed by grip strength test.
Measured: 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
The time of resolution of the motor block (in minutes or hours), assessed by grip strength tests.
Measured: From nerve block procedure to the resolution of the motor block, up to 48 hours
Onset time of sensory block
Onset time of sensory block is defined as the time (hour/minutes) from end of Ropiclobet injection to the onset of sensory block. This will be assessed by cold and touch tests across C5-C8 dermatomes.
Measured: Pre-block, and at 5, 10, 15, 20, 25, 30 minutes, as well as 6, 12, 24 and 48 hours post-injection.
Duration of sensory block
The time of resolution of the sensorial block (in minutes or hours)
Measured: From nerve block procedure to the resolution of the sensory block, up to 48 hours
Required rescue analgesia
Assessment of the frequency of required rescue analgesia intra-operatively.
Measured: Perioperative (from nerve block procedure to the end of surgery)
Required rescue analgesia
Assessment of the frequency of required rescue analgesia postoperatively
Measured: From the end of surgery up to 48 hours
Patient satisfaction
assessment of patient satisfaction using Visual Analog Scale (VAS), 0-10 scale (0=worst, 10=best)
Measured: 24 hours following nerve block procedure, and on Day 15 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start2 Sep 2025
- Primary completion3 Dec 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- PHARMAFINA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131657
- Sponsor's protocol ID
- PF_002
- Status last verified
- Jan 2026
- First submitted
- 31 Jul 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07131657
- Acronym / sponsor ID
- PF_002
- Conditions
- Nerve Block, Upper Extremity Surgery
- Keywords
- ropivacaine, clonidine, betamethasone, supraclavicular brachial nerve block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PHARMAFINAIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This national, single-center, single-arm, open-label Phase II clinical trial includes three dose groups and aims to evaluate the efficacy and safety of Ropiclobet. Ropiclobet Injectable Solution is a fixed-dose combination containing Ropivacaine HCl, Betamethasone Sodium Phosphate, and Clonidine HCl at concentrations of 5.0/0.4*/0.015 mg/mL (*the 10 mL ampoule contains 0.53 mg of betamethasone sodium phosphate, equivalent to 0.4 mg of betamethasone).
A total of 60 volunteers (Hospitalized patients in the orthopedic department or outpatients who are scheduled for surgery) undergoing upper extremity surgery (including arm, elbow, forearm, and hand surgeries) will receive a single administration of the Ropiclobet combination via supraclavicular brachial nerve blockade (SCB) under ultrasound guidance.
The study will include three dose groups:
- Group I: 10 mL Ropiclobet combination (1 ampoule) diluted with 10 mL of 0.9% isotonic saline
- Group II: 15 mL Ropiclobet combination (1.5 ampoules) diluted with 5 mL of 0.9% isotonic saline
- Group III: 20 mL Ropiclobet combination (2 ampoules), administered undiluted. There will be no randomization for dose groups. The first 20 participants will be assigned to Group I. The study team will assess safety and efficacy parameters in these participants. Following the completion of 20 participants in Group I, the study will proceed to Group II. Group III will follow in the same manner, with 20 participants planned per group.
Ropiclobet injection will be performed preoperatively under sterile conditions by an experienced anesthesiologist. Only sedation may be administered if needed, and volunteers requiring general anesthesia will be withdrawn from the study.
Standard monitoring will include ECG, non-invasive blood pressure measurement, and pulse oximetry. Postoperatively, volunteers will be monitored in the PACU for 2 hours, followed by observation in the hospital ward under an anesthesiologist's supervision. Volunteers will remain under clinical observation for 48 hours post-procedure. If motor or sensory blockade persists beyond this period, monitoring will continue until full resolution plus an additional 6 hours. Follow-up visits will be at Day 15 and Day 30.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nerve block arm | Experimental | Drug: Ropivacaine + Clonidine + BetamethasoneVolunteers will undergo supraclavicular brachial nerve block preoperatively using the combination drug Ropiclobet (Ropivacaine-Clonidine-Betamethasone) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine + Clonidine + BetamethasoneRopivacaine 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 | Nerve block arm |
| Ropivacaine + Clonidine + BetamethasoneRopivacaine 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 | Nerve block arm |
| Ropivacaine + Clonidine + BetamethasoneRopivacaine 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) | Drug | Nerve block arm |
Primary outcome
Duration of analgesia
Time frame: 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
Time frame: From the beginning of the nerve block procedure to the end of study visit at 30 days
9 secondary outcomes
Pain at rest
Time frame: pre-block, and 0, 2, 4, 6, 12, 18, 24 and 48 hours post-block, on Day 15 and 30.
Pain during movement
Time frame: 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
Time frame: 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
Time frame: From nerve block procedure to the resolution of the motor block, up to 48 hours
Onset time of sensory block
Time frame: Pre-block, and at 5, 10, 15, 20, 25, 30 minutes, as well as 6, 12, 24 and 48 hours post-injection.
Duration of sensory block
Time frame: From nerve block procedure to the resolution of the sensory block, up to 48 hours
Required rescue analgesia
Time frame: Perioperative (from nerve block procedure to the end of surgery)
Required rescue analgesia
Time frame: From the end of surgery up to 48 hours
Patient satisfaction
Time frame: 24 hours following nerve block procedure, and on Day 15 and 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ropivacaine + Clonidine + Betamethasone in people with Nerve Block and Upper Extremity Surgery, run by PHARMAFINA at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of analgesia (time frame: From end of Ropiclobet injection to the first sensation of pain at surgical site (minutes/hours), up to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.