Randomized Controlled Trial of Repeat vs. Single Quadratus Lumborum Block to Reduce Opioid Prescriptions After Open Pancreatectomy ("RESQU-BLOCK" Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Number of Participants Discharged Opioid-Free
研究概览
简要总结
This phase II trial studies how an additional anesthetic nerve block, called a quadratus lumborum block, works to reduce the need for opioids in patients after pancreatic surgery. Giving an additional regional anesthetic after surgery may hasten the weaning process, reduce the need for opioid medications upon discharge, and reduce the risk of opioid dependence.
详细描述
PRIMARY OBJECTIVE:
I. To use a phase II randomized controlled trial to compare the intervention of a second regional anesthetic block (quadratus lumborum [QL] block) versus usual care (single intraoperative QL block) to increase the proportion of opioid-free pancreatic cancer survivors at discharge after potentially curative surgery.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
ARM 2: Patients undergo QL block before surgery and receive multimodal pain control. Patients then undergo a second QL block on day 4 after surgery and continue to receive standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 pancreatic resection for potentially curative intent (pancreaticoduodenectomy or distal pancreatectomy) who would otherwise be treated with QL block + IV-PCA converted to oral pain 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.
研究组 & 干预措施
Arm I (QL block, standard of care)
Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
干预措施: Best Practice (Other)
Arm I (QL block, standard of care)
Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
干预措施: Quadratus Lumborum Block (Drug)
Arm I (QL block, standard of care)
Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
干预措施: Quality-of-Life Assessment (Other)
Arm I (QL block, standard of care)
Patients undergo QL block before surgery and receive standard of care multimodal pain control after surgery.
干预措施: Questionnaire Administration (Other)
Arm II (second QL block)
Patients undergo QL block before surgery and receive multimodal pain control. Patients then undergo a second QL block on day 4 after surgery and continue to receive standard of care.
干预措施: Best Practice (Other)
Arm II (second QL block)
Patients undergo QL block before surgery and receive multimodal pain control. Patients then undergo a second QL block on day 4 after surgery and continue to receive standard of care.
干预措施: Quadratus Lumborum Block (Drug)
Arm II (second QL block)
Patients undergo QL block before surgery and receive multimodal pain control. Patients then undergo a second QL block on day 4 after surgery and continue to receive standard of care.
干预措施: Quality-of-Life Assessment (Other)
Arm II (second QL block)
Patients undergo QL block before surgery and receive multimodal pain control. Patients then undergo a second QL block on day 4 after surgery and continue to receive standard of care.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Number of Participants Discharged Opioid-Free
时间窗: 90 days from surgery
Performed Chi-squared test to compare the proportion of patients who were opioid-free on the discharge date between the two arms
次要结局
- Total Inpatient Oral Morphine Equivalents (OME)(Up to 1 year)
- Pain Prescription Dosage/Size(through study completion, an average of 1 year)
- Percentage of Patients With Initial Discharge Prescription Dosage/Size Total OME < 200 mg(Up to 1 year)
- Percentage of Patients Using Opioids(At 90 days after surgery)
- MDASI-GI in Clinic Visits(Up to 1 year)
- Hospital Cost(Up to 1 year)
- Total OME for First 30 Days and First 90 Days (Inpatient + Outpatient)(At 30 and 90 days)
- Patients and Family Free of Opioid Use(At 6 months and 1 year)
- Quality of Life Score Assessed by MD Anderson Symptom Inventory-Gastrointestinal (MDASI-GI)(Up to 1 year)