Phase I Study of Ropivacaine, Clonidine, and Betamethasone Combination for Sciatic Nerve Block in the Popliteal Region

NCT06781632 | Completed Phase 1

• 1 other identifier: PF_001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a national, single-center, dose-escalation Phase I study to investigate the safety, pharmacokinetics, and efficacy of a combination containing Ropivacaine, Clonidine, and Betamethasone (Ropiclobet) in healty volunteers. After screening and eligibility confirmation, at least 28 participants will receive a sciatic nerve block in the popliteal region with Ropiclobet, followed by pharmacokinetic assessments through blood sampling and monitoring of motor and sensory nerve blocks in the tibial and common peroneal nerves. Safety evaluations, including physical exams, vital signs, ECGs, and sedation scores, will be conducted throughout the study. sensory blocks resolve. Participants will remain under observation for 48 hours post-procedure and will be discharged once motor and sensory blocks resolve. Follow-up visits will be conducted on Days 10 and 15 on an outpatient basis, with an end-of-study visit planned for Day 30. The dose-escalation protocol involves administering 5 mL, 10 mL, 15 mL, and 20 mL doses to sequential groups of participants, with safety assessments performed after each dose level before proceeding.

Conditions

Healthy; Nerve Block

Keywords

Ropivacaine; Clonidine; Betamethasone; Nerve Block

Outcome Measures

Primary Outcomes (4)

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

  The incidence of treatment-related adverse events, measured according to NCI-CTCAE criteria.

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

• Number of treatment-related adverse events assessed by laboratory parameters

  The incidence of treatment-related adverse events based on hematological, and biochemical parameters

  Before nerve block procedure, 24 and 48 hours after procedure, and during follow-up visits on Day 10, Day 15, Day 30

• Number of treatment-related adverse events assessed by ECG

  The incidence of treatment-related adverse events based on electrocardiography

  From nerve block procedure to discharge at 48 hours, and during follow-up visits on Day 10, Day 15, Day 30

• Number of treatment-related adverse events assessed by physical examination and vital signs

  The incidence of treatment-related adverse events based on physical examination and vital signs

  From nerve block procedure to discharge at 48 hours, and during follow-up visits on Day 10, Day 15, Day 30

Secondary Outcomes (8)

• Pharmacokinetics (concentration analysis)

  before the sciatic nerve block (at 0.hour) and post-block at 15, 30, and 45 minutes, and at 1, 2, 3, 4, 6, 8, 12, 18, 24, and 48 hours.

• Pharmacokinetics (concentration analysis)

  before the sciatic nerve block (at 0.hour) and post-block at 15, 30, and 45 minutes, and at 1, 2, 3, 4, 6, 8, 12, 18, 24, and 48 hours.

• Pharmacokinetics (concentration analysis)

  before the sciatic nerve block (at 0.hour) and post-block at 15, 30, and 45 minutes, and at 1, 2, 3, 4, 6, 8, 12, 18, 24, and 48 hours.

• Efficacy of ropiclobet assessed by onset of motor block

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

• Efficacy of ropiclobet assessed by duration of motor block

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

Study Arms (1)

Nerve Block Arm

EXPERIMENTAL

Volunteers will undergo sciatic nerve block in the popliteal region using the combination drug Ropiclobet (Ropivacaine-Clonidine-Betamethasone)

Drug: ropivacaine

Interventions

ropivacaine 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)

Also known as: clonidine, betamethasone

Nerve Block Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers based on the results of medical evaluation, including medical history, physical examination, neurological examination, laboratory tests, and cardiac monitoring, performed by the investigator.
• Between 18 and 45 years, male and female
• Provide a signed and dated written informed consent
• A negative pregnancy test at the screening visit for female volunteers with childbearing potential
• Negative alcohol breath test.
• Negative urine drug screening for addictive substances (amphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, opioids).
• Capable of completing all tests and evaluations related to the study.
• In the investigator's opinion, the volunteer must have the potential to comply with the study requirements.

You may not qualify if:

• Volunteers with hypersensitivity to local anesthesia/regional anesthesia.
• Volunteers with a known hypersensitivity to amide-based local anesthetics.
• Volunteers with chronic pain.
• Volunteers with neuromuscular diseases or peripheral neuropathy.
• Volunteers with bleeding disorders/coagulopathies.
• Volunteers with a history of motor or sensory loss in the lower extremities.
• Volunteers with a history of arrhythmia or seizures.
• Volunteers with renal or hepatic insufficiency.
• Volunteers diagnosed with diabetes.
• Volunteers with hereditary neuropathy.
• Volunteers with a body mass index (BMI) \> 35 kg/m².
• Pregnant, breastfeeding, or women with a positive pregnancy test.
• Volunteers with skin infections or wounds at the injection site.
• Volunteers with clinically significant abnormalities in the ECG, such as rhythm, conduction, or morphology issues, or any abnormalities on a 12-lead ECG that could interfere with the interpretation of QTc interval changes (including normal ST-T wave morphology or left ventricular hypertrophy), as determined by the investigator or medical monitor, or those on chronic use of antiarrhythmic medications.
• Volunteers with clinically significant abnormalities in vital signs during screening, which may include:

Sponsors & Collaborators

• PHARMAFINA: lead
• MonitorCRO: collaborator

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine Phase I and Clinical Research Center

Istanbul, 34093, 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 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 17, 2025
• Study Start: November 13, 2024
• Primary Completion: February 20, 2025
• Study Completion: April 25, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)