Single-injection Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Open Radical Prostatectomy: A Prospective Randomized Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Narcotic consumption in the first 24 hours after surgery
研究概览
简要总结
In the proposed study, a bilateral erector spinae plane (ESP) block [10 ml 1%lidocaine + 10 ml 0.5 % bupivacaine vs normal saline (NS)] will be performed preoperatively to patients undergoing open radical prostatectomy. Analgesic efficacy will be assessed on the numeric rating scale (NRS) along with intra- and 24 h post-operative narcotic consumption.
详细描述
It has been reported that the ESP block produces effective postoperative analgesia for abdominal surgeries by relieving both somatic and visceral pain. In the present study, the investigators presume that an ESP block will decrease narcotic consumption and NRS values both intraoperatively and during the first 24 postoperative hours.
Patients will be divided into two groups:
Group LB (Lidocaine-Bupivacaine): A bilateral ESP block will be performed preoperatively (10 ml 1%lidocaine + 10 ml 0.5% bupivacaine). In addition, IV morphine patient-controlled analgesia (PCA) will be applied postoperatively for 24 hours.
Group S: A bilateral ESP block will be performed preoperatively (20 ml NS).In addition, IV morphine-PCA will be applied postoperatively for 24 hours.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AmericanSociety of Anesthesiologists (ASA) I-III patients between the ages of 18 and 65 who are scheduled for elective open radical prostatectomy.
排除标准
- •Patients who do not give informed consent or do not want to participate in the study
- •Ages <18 or>65
- •ASA IV patients
- •Obesity (>100 kg, BMI >35 kg/m2)
- •Contraindications of regional anesthesia (coagulopathy, thrombocytopenia, or infection at injection site)
- •Serious renal, cardiac, or hepatic disease
- •Hypersensitivity to local anesthetics or a history of allergy
- •History of opioid or steroid use longer than four weeks
- •Psychiatric disorders
- •Analgesic preoperative treatment within the preceding 48 hours
- •In order to establish better standard surgery, operations shorter than 60 minutes and longer than 180 minutes will also be excluded
结局指标
主要结局
Narcotic consumption in the first 24 hours after surgery
时间窗: Postoperative day 1
Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 3.
次要结局
- Postoperative nausea and vomiting (PONV)(Postoperative day 1)
- Intraoperative remifentanil consumption(Postoperative day 1)
- Postoperative pain: NRS score(Postoperative day 1)
研究者
BURHAN DOST
Assistant Professor
Ondokuz Mayıs University