A Pain Relief Trial Utilizing the Infiltration of a Multivesicular Liposome Formulation of Bupivacaine, EXPAREL(R): A Phase 4 Health Economic Trial in Adult Patients Undergoing Laparoscopic Colectomy (IMPROVE-Lap Colectomy)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 122
- 试验地点
- 6
- 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 hospital 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 or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing laparoscopic colectomy 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, at least 18 years of age.
- •Patients scheduled to undergo laparoscopic segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy. (Note: patients who converted from a planned laparoscopic colectomy to an open colectomy were not eligible.)
- •Ability to provide informed consent, adhere to study visit schedule, and complete all study 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 least 1 month before and 1 month after dosing. Acceptable means of contraception include hormonal contraceptives (e.g., oral, injectable, implantable), effective barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, non-heterosexual lifestyle, or in a strictly monogamous relationship with a partner who has had a vasectomy.
- •Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
- •Participation in an EXPAREL study within the last 30 days.
- •Patients who have received any 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, a patient was ineligible if he or she met the following criteria during surgery:
- •Patients who had any concurrent surgical procedure.
- •Patients with unplanned multiple segmental resections of large intestine.
- •Patients who converted from laparoscopic-assisted colectomy to traditional open colectomy.
- •Patients who had unplanned, temporary or permanent colostomies, ileostomies, or the like placed.
- •Patients who received intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
- •Patients who received Entereg.
研究组 & 干预措施
IV Morphine Sulfate or Sponsor-approved Equivalent
Standard of Care (SOC)
干预措施: IV morphine sulfate or Sponsor-approved equivalent (Drug)
EXPAREL
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 hospital 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.
Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever was sooner.
Health Economic Benefits - Length of Stay (LOS)
时间窗: Wound closure at time hospital discharge order is written or Day 30, whichever is sooner
Length of stay, recorded in days, defined as the time of completion of the wound closure until the hospital discharge order is written or through Day 30, whichever is sooner.
次要结局
- Incidence of Opioid-related Adverse Events(Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.)
- Patient Satisfaction With Pain Treatment After Surgery(Wound closure at time hospital discharge order is written or Day 30, whichever is sooner.)