Quadratus Lumborum Block for Analgesia After Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (CRS and HIPEC): a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total opioid consumption for 24 postoperative hours
研究概览
简要总结
This study aims to assess whether transmusculr quadratus lomborum block (QL block) can reduce postoperative pain after cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC). Patients will be randomly assigned to either QL block group or control group. Ultrasound-guided bilateral transmuscular quadratus lomborum block will be performed in QL block group using 0.375% ropivacaine. Multimodal analgesic regimen including acetaminophen, nonsteroidal antiinflammatory drugs (NSAIDs), and rescue opioids will be used in every patient. Primary outcome is opioid consumption for 24 hours after surgery. Secondary outcomes included pain scores, time to first rescue analgesics, quality of recovery score, length of hospital stay.
详细描述
Adult patients scheduled to undergo cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy will be screened for eligibility. After induction of general anesthesia, ultrasound-guided bilateral transmuscular quadratus lomborum block will be done in QL block group. 0.375% ropivacaine will be injected to each side. Patients in control group will receive no block. Multimodal analgesia will be applied to every patient for postoperative pain control. Multimodal analgesic regimen included scheduled administration of acetaminophen, NSAIDs, and rescue opioids. Blinded investigator will assess pain scores at rest and on movement at 6, 12, 24, 48, 72 hours after surgery, analgesic consumptions, nausea, vomiting, and quality of recovery questionnaire.
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
- Double (Participant, Care Provider)
盲法说明
Patients, medical staff who measure outcome variables, and nurses in the recovery room are double-blinded so that medical staff and patients do not know the patient's assigned group.
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who are scheduled to undergo cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (CRS and HIPEC)
排除标准
- •Allergy to local anesthetics or fentanyl
- •Chronic pain
- •Patients who are unable to use patient-controlled analgesia
- •Skin infection at site for quadratus lomborum block
- •pregnant or breatfeeding women
- •Patients who are unable to communicate
结局指标
主要结局
Total opioid consumption for 24 postoperative hours
时间窗: 24 hours postoperatively
Total opioid analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))
次要结局
- Time to first rescue analgesics(within post-operative 24 hours)
- Resting pain numeric rating scale(NRS)(at postoperative 6, 12, 24, 48, 72 hours)
- Time to first ambulation(within post-operative 72 hours)
- Rescue analgesics administration(within post-operative 48 hours)
- The incidence of post-operative nausea and vomiting(within post-operative 72 hours)
- Analgesic consumption(at postoperative 6, 12, 48, 72 hours)
- Numeric rating scale of pain during movement(at postoperative 6, 12, 24, 48, 72 hours)
- Quality of Recovery Questionnaire (15-item Quality of Recovery)(At post-operative 72 hours)
- Numeric rating scale at post anesthetic care unit (PACU)(30 minutes after the end of operation)
- Length of hospital stay(within postoperative 30 days)
- Patient satisfaction with pain control(At post-operative 72 hours)
- Pattern of injectate spread on ultrasonography(During quadratus lumborum (QL) block procedure)
研究者
Young Song
Associate Professor
Gangnam Severance Hospital