Quadratus Lumborum Block for Analgesia After Living Donor Kidney Transplantation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Analgesic consumption for 24 postoperative hours
研究概览
简要总结
The aim of this study is to evaluate the postoperative analgesic effect of quadratus lumborum block in patient undergoing a living donor kidney transplant under general anesthesia.
详细描述
The purpose of this study was to investigate whether postoperative pain is significantly reduced when TQL block was additionally performed after surgery in patients undergoing living-donor kidney transplantation. Therefore, investigator hypothesized that the analgesic consumption for postoperative 24 hours will decrease in TQL group compared to the control group. For secondary outcomes, the pain score at rest/ movement up to 48 hours after surgery, the time until the first pain reliever is requested, whether and how often rescue analgesics are administered for 48 hours, the incidence and severity of nausea and vomiting during the 48 hours after surgery, patient's satisfaction with post-pain control and the number of hospital stays were investigated. Overall, the aim of this study is to evaluate the postoperative analgesic effect of quadratus lumborum block in patients undergoing a living donor kidney transplantation under general anesthesia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients over 19 years of age undergoing elective living donor kidney transplantation under general anesthesia in Seoul National University Hospital
排除标准
- •Patients with severe pain before surgery
- •Patients with a history hypersensitivity reactions on fentanyl or ropivacaine
- •Patients who cannot maintain patient-controlled analgesia (PCA) by themselves
- •④ Patients with skin diseases or infections in the area where quadratus lumborum block is applied
- •⑤ Any other cases that researchers determine that it is inappropriate for this clinical trial
研究组 & 干预措施
Transmuscular quadratus lumborum block group
Patients assigned to the Transmuscular Quadratus Lumborum (TQL) block group receive the Transmuscular Quadratus Lumborum block in a lateral decubitus position with the surgical site facing up before recovery of general anesthesia after surgery. For the block, 30cc of 0.375% ropivacaine is used.
干预措施: Transmuscular quadratus lumborum block (Procedure)
Control group
For patients assigned to the control group, 30cc of 0.9% normal saline is used for Transmuscular Quadratus Lumborum block.
干预措施: Placebo (Procedure)
结局指标
主要结局
Analgesic consumption for 24 postoperative hours
时间窗: 24 hours postoperatively
Total analgesic use for 24 hours after surgery (morphine milligram equivalents (MME))
次要结局
- Analgesic consumption(at postoperative 6, 12, 48 hours)
- Resting pain numeric rating scale(NRS)(at postoperative 6, 12, 24, 48 hours)
- Numeric rating scale of pain during movement(at postoperative 6, 12, 24, 48 hours)
- Time to first rescue analgesics(within post-operative 24 hours)
- Numeric rating scale at post anesthetic care unit (PACU)(30 minutes after the end of operation)
- Rescue analgesics administration(within post-operative 48 hours)
- The incidence of post-operative nausea and vomiting(within post-operative 48 hours)
- Patient satisfaction with pain control(At post-operative 48 hours)
- Pattern of injectate spread on ultrasonography(During procedure quadratus lumborum (QL) block)
- Sensory blockade(30 minutes after the end of operation)
- Quality of Recovery Questionnaire (15-item Quality of Recovery)(At post-operative 48 hours)
- The severity of post-operative nausea and vomiting(within post-operative 48 hours)
研究者
Sun-Kyung Park
Clinical Assistant Professor
Seoul National University Hospital