Bupivacaine Effectiveness and Safety in SABER Trial (BESST)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Durect
- 入组人数
- 331
- 试验地点
- 1
- 主要终点
- Supplemental Opioid Use
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.
The purpose of this study is to investigate safety (side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following various kinds of abdominal 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
- •Patients must be able to read and understand the consent form, provide written consent, complete trial-related procedures, and communicate with the trial staff
- •Males and females, 18 years of age and older scheduled to undergo elective general abdominal surgery
- •Patients must be healthy or have only mild systemic disease
- •BMI < 45
- •Patients must have ECG wave form within normal limits
- •Female and male patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial participation is completed
排除标准
- •Patients who are pregnant or lactating
- •Patients undergoing emergency surgery (unless full consent is obtained and all screening procedures are completed prior to surgery)
- •Significant concomitant surgical procedure
- •History of multiple prior laparotomy procedures
- •Cancer with known metastases pre-operatively, which are suspected to impact post-operative recovery or pain
- •Planned formation of stoma during surgery or plans to undergo another laparotomy procedure within 30 days post-operatively
- •Pre-operative evidence of sepsis or septic shock
- •Pre-operative evaluation that suggests a surgery may preclude full closure of the incision(s)
- •Patients with current or regular use of systemic steroids, anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors, who cannot be withdrawn from these medications
- •Patients with current or regular use of drugs known to significantly prolong the QTc interval
- •Patients with known hypersensitivity to local anesthetic agents of the amide type (e.g. lidocaine, bupivacaine)
- •Patients with known hypersensitivity to morphine
- •Patients with conditions contraindicated for use of opioids
- •Patients with atrial fibrillation/flutter or other non-sinus rhythm (including paced rhythm); left bundle branch block (LBBB); or the following conditions: right bundle branch block (RBBB) in presence of a cardiac disease, significant cardiomyopathy, and myocardial infarction within last 6 months
- •Patients with a serum creatinine level two times more than the local laboratory normal limit
- •Patients who have received greater than 600 mg morphine equivalent daily dose for three or more days per week in the month prior to the surgical procedure
- •Patients who are currently being treated with methadone, or history of methadone use within the previous 6 months
- •Patients with known or suspected abuse of opioids or other illicit drugs
- •Patients with known or suspected alcohol abuse
- •Participation in another clinical trial at the same time or within 30 days of this trial
- •Patients who, in the Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason
研究组 & 干预措施
Active: SABER-Bupivacaine
SABER-Bupivacaine
干预措施: SABER-Bupivacaine (Drug)
Comparator: Bupivacaine HCl
Bupivacaine HCl
干预措施: Bupivacaine HCl (Drug)
Placebo: SABER-Placebo
SABER-Placebo
干预措施: SABER-Placebo (Drug)
结局指标
主要结局
Supplemental Opioid Use
时间窗: 0-72 hours post dose
Total morphine-equivalent dose during 0-72 hours post dose. Median values were presented because data was not normally distributed.
Mean Pain Intensity on Movement
时间窗: 0 to 72 hours post-dose
Mean pain intensity on movement AUC (time-normalized AUC) during the period 0 to 72 hours post-dose. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. 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
- Total Morphine-equivalent Dose(0-48 hours post dose)
- Proportion (Percent) of Patients Who Have Evidence of a Wound Infection(0 to 14 days post-dose (Visits 3 and 4))
- Time-to-first Use of Opioid Rescue Medication(0 to 14 days post-dose (Time from extubation until first opioid use))
- Pain Intensity at Rest AUC During 0-72 Hours Post Dose(0-72 hours post dose)
- Mean Pain Intensity on Movement(0 to 48 hours post-dose)
- Number (Incidence) of Participants With Opioid-related Side Effects(0 to 30 days post-dose)
- Mean Pain Intensity at Rest AUC During 0-48 Hours Post Dose(0-48 hours post dose)