Randomized Controlled Trial of Repeat vs. Single Quadratus Lumborum Block to Reduce Opioid Prescriptions After Open Resection of Retroperitoneal Sarcoma ("RESQU-SARC" Trial)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Initial Discharge Prescription Oral Morphine Equivalents (OME)
研究概览
简要总结
This phase II trial studies how well a repeat or single liposomal bupivacaine injection (quadratus lumborum block) works in reducing opioid prescriptions after surgery in patients with retroperitoneal sarcoma. Liposomal bupivacaine is a numbing medication. Giving a second injection block may decrease dependency on opioid medications for pain relief after surgery and prevent long-term use and addiction.
详细描述
PRIMARY OBJECTIVE:
I. To use a pragmatic phase II randomized controlled trial to compare two standardized bundles of usual care for postoperative pain management to reduce the initial discharge prescription opioid volume.
SECONDARY OBJECTIVE:
I. To assess which pragmatic arm improves aspects of postoperative recovery including 30-day, 3-month, and 1-year opioid use, patient symptom inventory at those time points, hospital measures including length of stay and inpatient pain scores.
OUTLINE: Patients are randomized to 1 of 2 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 undergoing elective open sarcoma resection for potentially curative intent who would otherwise be treated with quadratus lumborum (QL) block + intravenous-patient controlled analgesia (IV-PCA) converted to oral pain medications (meds) (non-narcotic bundle + opioid pain pill)
排除标准
- •Patients with current or past substance (drug or alcohol) abuse disorder
- •Laparoscopic or minimally invasive surgery
- •Cases in which anticipated discharge is on or before postoperative day 4
研究组 & 干预措施
Arm I (liposomal bupivacaine)
Patients receive standard of care liposomal bupivacaine injection before and during surgery and standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity.
干预措施: Liposomal Bupivacaine (Drug)
Arm II (liposomal bupivacaine)
Patients receive standard of care liposomal bupivacaine injection before and during surgery and standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity. Patients then receive a second liposomal bupivacaine injection on day 4 after surgery.
干预措施: Liposomal Bupivacaine (Drug)
Arm I (liposomal bupivacaine)
Patients receive standard of care liposomal bupivacaine injection before and during surgery and standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm II (liposomal bupivacaine)
Patients receive standard of care liposomal bupivacaine injection before and during surgery and standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity. Patients then receive a second liposomal bupivacaine injection on day 4 after surgery.
干预措施: Quadratus Lumborum Block (Drug)
Arm II (liposomal bupivacaine)
Patients receive standard of care liposomal bupivacaine injection before and during surgery and standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity. Patients then receive a second liposomal bupivacaine injection on day 4 after surgery.
干预措施: Questionnaire Administration (Other)
Arm I (liposomal bupivacaine)
Patients receive standard of care liposomal bupivacaine injection before and during surgery and standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity.
干预措施: Quadratus Lumborum Block (Drug)
结局指标
主要结局
Initial Discharge Prescription Oral Morphine Equivalents (OME)
时间窗: At time of discharge (median of 9 days)
After sarcoma surgery, our historical discharge opioid prescription was a median of 300mg oral morphine equivalents (OME) in 2016-2018, with 5% patients discharged opioid-free. The primary objective of this study was to compare 2 novel opioid-reduction bundles to increase the proportion of opioid-free patients.
次要结局
- Proportion of Participants With Discharge Prescription OME = Zero(At time of discharge (median of 9 days))
- Participant Reported Outcomes for Gastrointestinal Surgery- MD Anderson Symptom Inventory (MDASI-GI) at Discharge and 1 Month After Surgery.(Scores at discharge and 1 month after the surgery)