A Double-Blind, Placebo-Controlled, Pharmacodynamic and Pharmacokinetic Dose Response Study of SABER-Bupivacaine Instilled Into the Wound in Patients Undergoing Open Inguinal Hernia Repair
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Durect
- 入组人数
- 124
- 主要终点
- Proportion (Percent) of Patients Using Supplemental Opioids
研究概览
简要总结
This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. This study is testing SABER-Bupivacaine in people having surgery to repair a hernia.
The purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of SABER-Bupivacaine with SABER-Placebo.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18 to 65 years of age, scheduled for hernia repair surgery
- •Patients must be in good health prior to study participation
- •Patients must have blood pressure within normal range or with Stage 1 high blood pressure
- •Male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed
- •Patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial
- •Ability to read, understand, communicate, and voluntarily sign the informed consent form prior to any trial specific procedures
排除标准
- •Patients with previous abdominal surgery scar tissue
- •Patients with clinically significant abnormalities of any body system unrelated to the disease under study
- •Connective tissue disorders
- •Patients who are pregnant or lactating
- •Current or regular use of analgesic medication for other indications
- •Patients with current or regular use of antidepressants or monoamine oxidase inhibitors at screening
- •Use of any drugs or medication that may interfere with the study and its results
- •Patients with known hypersensitivity to the study drugs or their components
- •Patients with known or suspected alcohol abuse or illicit drug use
- •Participation in another clinical trial at the same time or within 30 days of this trial
- •Patient is unwilling to comply with the study procedures
研究组 & 干预措施
Group 1: SABER-Bupivacaine
2.5 mL SABER-Bupivacaine/Once
干预措施: SABER-Bupivacaine (Drug)
Group 2: SABER-Bupivacaine
5.0 mL SABER-Bupivacaine/Once
干预措施: SABER-Bupivacaine (Drug)
Group 3: SABER-Placebo
2.5 mL or 5.0 mL SABER-Placebo/Once
干预措施: SABER-Placebo (Drug)
结局指标
主要结局
Proportion (Percent) of Patients Using Supplemental Opioids
时间窗: 0 to 14 days post-dose
Pain Intensity on Movement
时间窗: 1 to 72 hours post-dose
Pain intensity on movement normalized AUC over the time period 1 to 72 hours post-surgery. Data on pain intensity were collected using a 0 to 10 NRS with scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
次要结局
- Supplemental Opioid Use(0 to 14 days post-dose)
- Pain Intensity(1 to 48 hours post-dose)
- Treatment Satisfaction(1 to 5 days post-dose)
- Mean Function Activities (Modified Brief Pain Inventory)(1 to 5 days post-dose)