The Use of Liposomal Bupivacaine (Exparel) in Soft Tissue Sarcoma Resection
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of participants with peak pain scores measured by VAS less than 7
研究概览
简要总结
The purpose of this research is to study a medication called liposomal bupivacaine (EXPAREL®). Study doctors want to see if it is safe, if it can reduce pain after surgery, and the study doctor want to study its use after the removal a soft tissue tumor called a sarcoma
详细描述
The hypothesis for this project is that using liposomal bupivacaine will reduce patients' morphine equivalent usage postoperatively while maintaining similar pain scores and lengths of stay when compared to patients that did not receive intraoperative liposomal bupivacaine. Thus, if the use of liposomal bupivacaine proves to aid in pain control and the reduction of initial opiate use following soft tissue sarcoma resection, it could be reasonably suggested that liposomal bupivacaine become incorporated into a multimodal form of pain management following soft tissue sarcoma resection. These results are expected to have a significant positive impact; allowing for a reduction in narcotic pain medication usage and its associated side effects while decreasing health care expenditures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients with a soft tissue sarcoma of the thigh
- •Must have sufficient health to withstand the physical demands of surgery
- •≥ 18 years old
- •ECOG performance status of ≤ 2
- •Ability to understand and the willingness to sign an IRB-approved informed consent document
排除标准
- •History of clinically significant medical conditions including: Cardiovascular: Atrial Fibrillation, Ventricular Fibrillation, Significant Coronary Artery Disease. Hepatic: Viral or Autoimmune Hepatitis, Cirrhosis of the Liver, Liver Metabolism Disorders. Renal: Any form of renal impairment. EXPAREL® is cleared by the kidneys, thus any form of renal impairment could lead to an adverse reaction.
- •Medical condition(s) or concurrent surgery that may have required analgesic treatment in the postoperative period for pain that was not strictly related to the study surgery.
- •Any clinically significant event or condition discovered during surgery that may have complicated the patient's post surgical course such as vascular or nerve involvement that was unknown before surgery.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to liposomal bupivacaine.
- •Pregnant women are excluded from this study because EXPAREL has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with EXPAREL, breastfeeding should be discontinued if the mother is treated with EXPAREL.
研究组 & 干预措施
Liiposomal Bupivacaine Group
Qualified participants with a soft tissue sarcoma of the thigh will be given the alternative protocol utilizing liposomal bupivacaine (Exparel®). The alternative protocol will utilize general or spinal anesthesia, but will also include the use of intraoperative liposomal bupivacaine instead of a regional nerve block.
干预措施: Liposomal Bupivacaine (Drug)
结局指标
主要结局
Number of participants with peak pain scores measured by VAS less than 7
时间窗: Up to 24 hours
Feasibility of Exparel for post surgical pain management in soft-tissue sarcoma surgeries of the thigh will be defined as peak pain score measured by VAS (Visual Analogue Scale) less than 7. VAS scores range 0 (no pain) to 10 (unbearable pain). Higher scores denote worse outcome measures.
次要结局
- Number of surgical-related infection(6 week post surgery)
- Amount of opiate use post-operatively while the patient is in the hospital in milligram morphine equivalent (MME)(Up to 5 days)
- Average Pain Scores during hospitalization(up to 5 days)
- Length of time in hospital(End of hospitalization (up to 30 days))
- Rate of approached and consented patients(end of the study up to 2 years)
- Peak Pain Scores during hospital stay post surgery(Up to 5 days)