A Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane Versus Standard of Care in Subjects Undergoing Elective Cesarean Section (CHOICE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 18
- 主要终点
- Total Postsurgical Opioid Consumption Through 72 Hours
研究概览
简要总结
The purpose of this study is to compare total opioid consumption by subjects in different treatment groups.
Another purpose of this study is to assess how well EXPAREL works, collect any safety data and assess your satisfaction using EXPAREL.
详细描述
This is a Phase-4, multicenter, randomized, active-controlled study in approximately 182 adult women undergoing elective C-section. All subjects will remain in the hospital for up to 72 hours post surgery.
Subjects will be screened within 30 days prior to surgery. During the screening visit, subjects will be assessed for any past or present medical conditions that in the opinion of the investigator would preclude them from study participation.
After the Informed Consent Form (ICF) is signed, a medical history, surgical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, alcohol breath test and urine drug screen, and clinical laboratory tests (hematology and chemistry) will be performed.
On Day 1, prior to the C-section, eligible subjects will be randomized in a 1:1:1 ratio into one of the three treatment groups listed below:
- Group 1: 150 mcg Duramorph® (SOC arm)+ postoperative multi-modal pain regimen as defined in this protocol. No EXPAREL TAP infiltration following skin-incision closure.
- Group 2: 50 mcg Duramorph + EXPAREL TAP infiltration following skin-incision closure + postoperative multi-modal pain regimen as defined in this protocol.
- Group 3: EXPAREL TAP infiltration following skin-incision closure + postoperative multi-modal pain regimen as defined in this protocol. No Duramorph.
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
- None
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
- •Females 18 years of age and older at screening.
- •Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.
- •American Society of Anesthesiology (ASA) physical status 1, 2, or
- •Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.
排除标准
- •Subjects who, in the opinion of the study site principal investigator, have a high-risk pregnancy.
- •Subjects with a pregnancy-induced medical condition or complication.
- •Subjects with 3 or more prior C-sections.
- •Pre-pregnancy body mass index >50 kg/m
- •Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications.
- •Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
- •Severely impaired renal or hepatic function.
- •Subjects at an increased risk for bleeding or a coagulation disorder.
- •Concurrent painful physical condition that may require analgesic treatment in the postsurgical period for pain that is not strictly related to the surgery.
- •Clinically significant medical disease in either the mother or baby that, in the opinion of the investigator, would make participation in a clinical study inappropriate.
- •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.
- •Previous participation in an EXPAREL study.
- •Any clinically significant event or condition uncovered during the surgery that might render the subject medically unstable or complicate the subject's postsurgical course.
- •Receives the epidural component of combined spinal epidural (CSE) anesthesia during the study.
研究组 & 干预措施
Group 1 (Standard of Care Group)
150 mcg Duramorph® + postoperative multi-modal pain regimen. No EXPAREL TAP infiltration
干预措施: 150 mcg Duramorph + multi-modal pain regimen (Drug)
Group 2 (Duramorph + EXPAREL TAP)
50 mcg Duramorph + EXPAREL TAP infiltration + postoperative multi-modal pain regimen.
干预措施: 50 mcg Duramorph+ EXPAREL + multi-modal pain regimen (Drug)
Group 3 (EXPAREL TAP)
EXPAREL TAP infiltration + postoperative multi-modal pain regimen. No Duramorph.
干预措施: Exparel TAP + multi-modal pain regimen (Drug)
结局指标
主要结局
Total Postsurgical Opioid Consumption Through 72 Hours
时间窗: Through 72 hours post-surgery
To Compare total opioid consumption through 72 hours following EXPAREL infiltration into the Transversus abdominus plane (TAP) with SOC in subjects undergoing an elective C-section
次要结局
- Percentage of Opioid-free Subjects(through 72 hours or hospital discharge, whichever came first)
- Severity of Itching (Numeric Rating Scale Score)(through 72 hours after surgery)
- Opioid Related Symptom Distress Scale Score (ORSDS)(through 72 hours after surgery)