A Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupivacaine vs. Bupivacaine Only Administered as Combined Sciatic (in Popliteal Fossa) and Adductor Canal Nerve Block for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Magnitude of analgesic effect
研究概览
简要总结
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 81 subjects undergoing lower extremity surgeries with combined sciatic and adductor canal nerve block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adult male or female volunteers ages 18 or older
- •American Society of Anesthesiologists (ASA) physical status 1, 2 or
- •Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
- •Body Mass Index ≥18 and ≤40 kg/m2
排除标准
- •Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
- •Documented history of long-term diabetes, renal (serum creatinine level >2mg/dL [176.8 μmol/L]) or hepatic dysfunction (serum alanine or aspartame transferase > 3 times the upper limit of normal), coagulation or bleeding disorder and severe peripheral vascular disease
- •Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion may confound the post dosing assessments
- •History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
- •Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
- •Previous participation in EXPAREL study
- •Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
- •Currently pregnant, nursing, or planning to become pregnant during the study
- •Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study
- •Currently on neuroleptic agent [e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.]
- •Inadequate sensory function on the foot (monofilament test)
- •Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)
- •In addition, the subject may be withdrawn from the study if the subject meets the following criterion during or post-surgery:
- •Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course
研究组 & 干预措施
Cohort 1, Group 1
Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL.
EXPAREL will be mixed with Bupivacaine
Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety.
干预措施: EXPAREL 13.3Mg/mL Suspension for Injection (Drug)
Cohort 1, Group 2
Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine.
Subjects enrolled in Cohort 1 will provide blood samples and measures for efficacy and safety.
干预措施: Bupivacaine Hydrochloride (Drug)
Cohort 2, Group 1
Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with EXPAREL.
EXPAREL will be mixed with Bupivacaine
Subjects enrolled in Cohort 2 will provide measures for efficacy and safety.
干预措施: EXPAREL 13.3Mg/mL Suspension for Injection (Drug)
Cohort 2, Group 2
Subjects in this group will receive ultrasound guided combined sciatic (in popliteal fossa) and adductor canal nerve block with bupivacaine.
Subjects enrolled in Cohort 2 will provide measures for efficacy and safety.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Magnitude of analgesic effect
时间窗: 0 hours to 96 hours
Area under the Curve of the NRS Pain intensity scores from 0 hours to 96 hours post-surgery.
次要结局
- Total Postsurgical Opioid Consumption(0 hours to 96 hours)