NCT04102267已完成4 期
A Randomized, Phase 4 Study of the Efficacy, Safety, and Pharmacokinetics of Bupivacaine Administered as Liposomal Bupivacaine or Continuous Infusion Via Elastomeric Pump Following Unilateral Open Inguinal Herniorrhaphy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) through 72 hours (AUC0-72)
研究概览
简要总结
This is a phase 4, randomized, open-label study of the efficacy, safety, and pharmacokinetics of bupivacaine administered as liposomal bupivacaine or continuous infusion via elastomeric pump following unilateral open inguinal herniorrhaphy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Is scheduled to undergo a unilateral open inguinal herniorrhaphy with mesh under general anesthesia
- •Has an American Society of Anesthesiologists Physical Status of I, II, or III
- •Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile,or using acceptable contraceptives.
排除标准
- •Had any prior inguinal hernia repair
- •Has a planned concurrent surgical procedure
- •Has other pre existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain
- •Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications
- •Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
- •Has taken any NSAIDs within least 10 days prior to the scheduled surgery
- •Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting)
- •Has been administered bupivacaine within 5 days prior to the scheduled surgery.
- •Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.
- •Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug
- •Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments
- •Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C
- •Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments
- •Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
- •Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. Note: Subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study. Subjects taking medical marijuana are not allowed to participate in the study.
- •Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives
- •Has undergone 3 or more surgeries within 12 months
- •Has a body mass index (BMI) >39 kg/m2.
研究组 & 干预措施
Liposomal bupivacaine injection (Group 1)
Experimental
Liposomal bupivacaine 266 mg via injection
干预措施: Bupivacaine liposome injectable suspension (Drug)
Bupivacaine HCl continuous infusion (Group 2)
Experimental
Bupivacaine HCl 300 mg via continuous infusion
干预措施: Bupivacaine HCl without epinephrine via continuous infusion (Drug)
结局指标
主要结局
Mean area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A) through 72 hours (AUC0-72)
时间窗: 72 hours
次要结局
- Median time in hours to first opioid rescue medication(72 hours)
- Total postoperative opioid consumption (in morphine equivalents)(72 hours)
- Proportion of subjects who are opioid-free(72 hours)
- Mean AUC0-72 of the NRS-R pain intensity scores.(72 hours)
研究者
研究点 (1)
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