Application of Anterior Quadratus Lumborum Block at the Lateral Supra-arcuate Ligament Under Laparoscopic Direct Vision in Laparoscopic Renal Surgery：A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- intravenous morphine equivalents
研究概览
简要总结
Evaluation of the effectiveness of Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision compared to local infiltration anesthesia for postoperative analgesia after laparoscopic renal surgery in patients.A randomized controlled trial involving 66 patients undergoing laparoscopic renal surgery will assign them randomly to an experimental group or a control group.The patients in experimental group will receive Anterior Quadratus Lumborum Block at the lateral supra-arcuate ligament under laparoscopic direct vision.The patients in control group will receive local infiltration anesthesia.The primary outcome measure is the cumulative consumption of intravenous morphine equivalents at postoperative 24 hours.The secondary outcomes include the cumulative consumption of intravenous morphine equivalents at postoperative 2, 4, 6, 12 and 48 hours, Numeric Rating Scale(NRS) score at rest and during activity (coughing) at postoperative 2, 6, 24 and 48 hours, Global Comfort Questionnaire(GCQ) Comfort Status Scale Score, Quality of Recovery-15(QoR-15) Postoperative Recovery Scale Score, time of the first press on the Patient-Controlled Analgesia pump, nausea, vomiting, skin itching, drowsiness, or other adverse reactions, regional anesthesia-related complications such as local anesthetic toxicity and length of postoperative hospital stay after surgery.
详细描述
The patients were 1:1 randomly assigned into groups by a clinical researcher not involved in the clinical procedures or data collection. The random numbers were generated by R studio 4.1.0 (R studio, Boston, MA, USA) software in a 1:1 ratio, with a block size of 8 for each group. The generated random numbers were sealed in opaque envelopes with sequential numbers. On the day of surgery, the envelope was opened by the protocol executor according to the recruitment order before the induction of general anesthesia.Data collection is in the charge of special personnel, and Case Report Form shall be filled in timely after data collection. At the same time, the electronic database was edited by Excel, and the electronic database was entered timely after filling in the paper Case Report form.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 80 years old;
- •American Society of Anesthesiologists (ASA) physical status classification: I to III;
- •Undergoing laparoscopic nephrectomy or partial nephrectomy (including robotic-assisted laparoscopic nephrectomy and partial nephrectomy).
排除标准
- •Recent use of anticoagulant medications or abnormal coagulation function;
- •Local infection at the puncture site or the presence of tumors, severe deformities, or systemic infection;
- •Severe renal failure (serum creatinine > 442 μmol/L or requiring renal replacement therapy) or liver dysfunction (Child-Pugh Class C);
- •Known allergy to local anesthetics or a family history of local anesthetic allergy;
- •Preoperative cognitive impairment or inability to assess pain;
- •Alcoholism, drug abuse, chronic opioid dependence, or the use of analgesics or psychotropic medications for more than 3 months;
- •History of central and/or peripheral nervous system disorders or myasthenia gravis;
- •Planned admission to the ICU;
- •Surgical cancellation or patient refusal, etc.
结局指标
主要结局
intravenous morphine equivalents
时间窗: Postoperative 24 hours
The cumulative consumption of intravenous morphine equivalents
次要结局
- Global Comfort Questionnaire(Preoperative and postoperative 24 hours)
- adverse reactions(Postoperative 72 hours)
- intravenous morphine equivalents(Postoperative 2, 4, 6, 12 and 48 hours)
- Quality of Recovery-15(Postoperative 24 hours)
- Numeric Rating Scale(postoperative 2, 6, 24 and 48 hours)
- Regional anesthesia-related complications(Postoperative 72 hours)
- Length of hospital stay(Postoperative 10 days)
- Time of the first press on Patient-Controlled Analgesia(Postoperative 48 hours)