A Phase 2B, Randomized, Controlled Study of HTX-011 Administered Via Pectoral Nerve Block in Subjects Undergoing Upper Extremity Surgery for Augmentation Mammoplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 2
- 主要终点
- Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 24 Hours Postsurgery (AUC0-24).
研究概览
简要总结
This is a Phase 2B, randomized, assessor-blind, active- and saline placebo-controlled, multicenter study in subjects undergoing augmentation mammoplasty to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 when administered via ultrasound-guided lateral and medial pectoral nerve block before surgery.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Is scheduled to undergo primary bilateral submuscular augmentation mammoplasty with saline or silicone smooth implants with a volume of 300 to 500 cc, inclusive. Note: textured implants are not allowed.
- •Has an American Society of Anesthesiologists Physical Status of I, II, or III.
- •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
- •Has a planned concurrent surgical procedure.
- •Has a planned reconstructive procedure status post breast cancer therapy.
- •Has a 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 medication.
- •Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
- •Has taken NSAIDs within 10 days prior to scheduled surgery.
- •Has been administered bupivacaine within 5 days prior to the scheduled surgery.
- •Has been administered any local anesthetic within 72 hours prior to the scheduled surgery other than to treat an AE that occurs after signing the ICF or for pretreatment prior to a needle placement.
- •Has initiated treatment with any of the following medications within 1 month prior to study drug administration or is taking any of these medications to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin, duloxetine, or cyclooxygenase-2 (COX-2) inhibitors. (Note: If a subject is taking one of these medications for a reason other than pain control, she must be on a stable scheduled dose [ie, not "as needed"] for at least 1 month prior to study drug administration.) Anxiolytics prior to surgery are permitted, if necessary.
- •Has a medical condition 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, Hepatitis C, or human immunodeficiency virus (HIV).
- •Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
- •Has any chronic neuromuscular deficit of either pectoral nerve function or arm/shoulder/truncal musculature.
- •Has any chronic condition or disease that would compromise neurological or vascular assessments.
- •Had a malignancy in the last year, with the exception of non-metastatic 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 in 12 months.
- •Has a body mass index (BMI) >35 kg/m2.
研究组 & 干预措施
Group 1: HTX-011
HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block.
干预措施: HTX-011 (Drug)
Group 2: HTX-011
HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block.
干预措施: HTX-011 (Drug)
Group 3: HTX-011
HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block.
干预措施: HTX-011 (Drug)
Group 4: HTX-011
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block.
干预措施: HTX-011 (Drug)
Group 5: HTX-011
HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation.
干预措施: HTX-011 (Drug)
Group 6: Bupivacaine HCl
Bupivacaine HCl without epinephrine, 50 mg via nerve block.
干预措施: Bupivacaine HCl without epinephrine (Drug)
Group 7: Saline Placebo
Saline placebo via nerve block.
干预措施: Saline Placebo (Drug)
结局指标
主要结局
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 24 Hours Postsurgery (AUC0-24).
时间窗: 24 hours
Pain intensity is assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-24 is 0-240. The prescribed activity for NRS-A is keeping the elbows at the side and against the body and then raising both hands in front of the abdomen with hands clasped and holding that position for at least 5 seconds.
次要结局
- Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)(72 Hours)