A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation Of BupiVacaine, EXPAREL®: A Phase 4 Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Total Opioid Burden
研究概览
简要总结
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.
详细描述
This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL (bupivacaine liposome injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Male or female, 18 years of age and older
- •Patients scheduled to undergo ileostomy reversal
- •Ability to provide informed consent, adhere to study visit schedule, and complete all assessments.
排除标准
- •Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol.
- •Patients who abuse alcohol or other drug substance.
- •Patients with severe hepatic impairment.
- •Patients currently pregnant or who may become pregnant during the course of the study or who are unwilling to use acceptable means of contraception for at lest one month before and one month after dosing.
- •Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
- •Patients who have participated in an EXPAREL study within the last 30 days.
- •Patients who have received an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study.
- •In addition, the patient will be ineligible if he/she meets the following criteria during surgery:
- •Patients who have any concurrent surgical procedure.
- •Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
- •Patients who receive Entereg(R).
研究组 & 干预措施
Group 1
IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)
干预措施: IV morphine sulfate or Sponsor-approved equivalent (Drug)
Group 2
EXPAREL (bupivacaine liposome injectable suspension)
干预措施: EXPAREL (Drug)
结局指标
主要结局
Total Opioid Burden
时间窗: Wound closure to time the discharge order is written or Day 30, whichever is sooner
Total opioid consumed (IV and PO) postsurgically until hospital discharge order is written or through Day 30, whichever is sooner.
Health Economic Benefits - Total Cost of Hospitalization
时间窗: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
1) Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.
Health Economic Benefit - Length of Stay
时间窗: Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.
Time from completion of wound closure until hospital discharge written or through Day 30, whichever was sooner
次要结局
- Readmission to Hospital Since Discharge(Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.)
- Make Unplanned VIsit(s) With Any Healthcare Providers(Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.)
- Incidence of Opioid-related Adverse Events(Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.)
- Patient Satisfaction With Postsurgical Analgesia(Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.)
- Patient Discharged From the Hospital for at Least 3 Days(Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.)
- Experienced Any Health Problems or Changed in Health Since Hospital Discharge(Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.)
- Contact or Attempt to Contact Surgeon/Doctor to Discuss Recovery After Surgery(Wound closure to time hospital discharge order is written or Day 30, whichever is sooner.)