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 Open Colectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 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(R) 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 compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 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 open segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy.
- •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.
- •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.
- •Patients who undergo any concurrent surgical procedure during the ileostomy reversal surgery
- •In addition, the patient will be ineligible if he/she meets the following criteria during surgery:
- •Patients who have any concurrent surgical procedure.
- •Patients with unplanned multiple segmental resections or large intestine.
- •Patients who have unplanned, temporary or permanent colostomies, ileostomies, or the like placed.
- •Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or an other analgesic, local anesthetics, or anti-inflammatory agents.
- •Patients who receive Entereg(R).
研究组 & 干预措施
IV morphine sulfate
Standard of Care (SOC), dosage variable, administered intravenously via PCA pump postsurgically, as need.
干预措施: IV morphine sulfate (Drug)
EXPAREL (bupivacaine liposome injectable suspension)
EXPAREL(R), dosage 266 mg, diluted with 0.9% saline to a total volume of 40 cc.
干预措施: EXPAREL (bupivacaine liposome injectable suspension) (Drug)
结局指标
主要结局
Total Opioid Burden
时间窗: Wound closure to time hospital discharge order written or Day 30, whichever is sooner
Total opioid consumed (IV and PO) postsurgically until the 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 written or Day 30, whichever is sooner.
Total cost of hospitalization until the time hospital discharge order is written or through Day 30, whichever is sooner.
Health Economic Benefits - Length of Stay
时间窗: Up to Day 30
Length of stay (LOS), recorded in hours and converted to days with one decimal of precision, 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 Predefined Opioid-related Adverse Events(From the time the informed consent is signed to the time hospital discharge order is written or through Day 30 (after surgery), which ever is sooner)