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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Duration of analgesia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Nerve block arm
Volunteers will undergo supraclavicular brachial nerve block preoperatively using the combination drug Ropiclobet (Ropivacaine-Clonidine-Betamethasone)
干预措施: Ropivacaine + Clonidine + Betamethasone (Drug)
结局指标
主要结局
Duration of analgesia
时间窗: 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
时间窗: From the beginning of the nerve block procedure to the end of study visit at 30 days
次要结局
- Required rescue analgesia(From the end of surgery up to 48 hours)
- Pain at rest(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.)
- 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.)
- Duration of sensory block(From nerve block procedure to the resolution of the sensory block, up to 48 hours)
- Patient satisfaction(24 hours following nerve block procedure, and 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)
- Duration of motor block(From nerve block procedure to the resolution of the motor block, up to 48 hours)
- Required rescue analgesia(Perioperative (from nerve block procedure to the end of surgery))