Efficacy of Liposomal Bupivacaine in Benign Soft Tissue Tumor Resection: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Opioid Use
研究概览
简要总结
Liposomal bupivacaine (Exparel) has been used as an adjunct to pain management in the perioperative setting. However, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. The goal of the study is to see if Exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard Bupivacaine HCL.
详细描述
Liposomal bupivacaine (Exparel) has been used as an adjunct to pain management in the perioperative setting. However, the efficacy of the drug has not bewen studied in patients with benign soft tissue tumor resections. The goal of the study is to see if Exparel controls pain and improves functional outcomes for patients after these procedures compared to the current standard Bupivacaine HCL.
Patients will be randomly assigned Exparel or Bupivacaine HCL intraoperatively during the tumor resection. The amount administered is based on the size of wound after tumor resection. The patients are then provided a pain diary in which they record the amount of pain medications taken, VAS pain scores, and musculoskeletal and tumor society score (MSTS) for the first week postoperatively.
The study will end once 140 patients have been enrolled. Data will be analyzed comparing morphine equivalents, pain scores, and functional scores between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All benign soft tissue tumors greater than one cubic cm
- •Adults 18 years and older
排除标准
- •Pregnant females
- •Women who are breastfeeding
- •Less than 18 years old
- •Malignant tumors
- •Tumors smaller than 1 cubic cm
- •Allergy to Exparel
- •Patients who are opioid dependent defined as patients on a long acting narcotic or who take more than 30 morphine equivalents per day
- •Allergy to amide anesthetics
- •bone tumors
- •Patients unable to comply with the study standards and follow up
研究组 & 干预措施
experimental
Exparel group
干预措施: Liposomal bupivacaine (Drug)
control
plain bupivacaine
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Opioid Use
时间窗: first 7 days postoperatively
Amount of morphine equivalents used for postoperative pain control
次要结局
- Pain Score(First 7 days postoperatively)