A Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic (in Popliteal Fossa) and Saphenous (in Adductor Canal) Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 5
- 主要终点
- Magnitude of the Analgesic Effect (NRS Pain Intensity) (AUC)
研究概览
简要总结
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 3
- •Able to provide informed consent, adhere to the study schedule, and complete all study assessments
- •Body Mass Index (BMI) ≥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 (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, nonsteroidal anti-inflammatory drugs [NSAIDs])
- •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 an 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 diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction or other conditions that would constitute a contraindication to participation in the study.
- •Currently on a neuromodulating agent neuroleptic agent (e.g., gabapentin, pregabalin [Lyrica], duloxetine [Cymbalta], etc.)
- •Inadequate sensory function on the foot (monofilament test)
- •Chronic opioid use within 30 days prior to randomization (average ≥30 oral morphine equivalents/day)
研究组 & 干预措施
EXPAREL arm
Subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL mixed with 20 mL saline
干预措施: Exparel (Drug)
EXPAREL admix arm
subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl.
干预措施: Exparel (Drug)
EXPAREL admix arm
subjects randomized to this treatment arm will receive 20 mL (266 mg)EXPAREL admixed with 20 mL (50 mg) 0.25% bupivacaine HCl.
干预措施: Bupivacaine Hydrochloride (Drug)
Bupivacaine HCl Arm
subjects randomized to this treatment arm will receive 40 mL (100 mg)0.25% bupivacaine HCl.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Magnitude of the Analgesic Effect (NRS Pain Intensity) (AUC)
时间窗: Post surgery - 96 hours
To compare the magnitude of the analgesic effect (NRS pain intensity scores) following a single dose injection of EXPAREL vs. bupivacaine hydrochloride (HCl) when administered as combined sciatic (in the popliteal fossa) and saphenous (in the adductor canal) nerve blocks in subjects undergoing lower extremity surgeries. Numerical Rating Scale: an 11 point scale 0=no pain, 10= the worst pain imaginable. The area under the curve (AUC) of the NRS pain intensity scores from 0 to 96 hours post-surgery comparing EXPAREL to 0.25% bupivacaine HCl
次要结局
- Total Opioid Consumption(0 hours to 96 hours)
- Time to First Opioid(Post Surgery through Day 14)