The Effect of Timing of Rectus Sheath Blockade During Robotic Prostate Surgery on Opioid Consumption: A Randomized Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Total intraoperatif remifentanil consumption
研究概览
简要总结
The aim of this study is to observe the effect of administering local anesthetic to the abdominal wall at the beginning or end of surgery under general anesthesia on opioid consumption during surgery. The hypothesis of this study is to demonstrate that administering a rectus sheath block before the surgical procedure under general anesthesia is effective in reducing intraoperative opioid consumption and opioid-related side effects compared to administering it after the surgery is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA (American Society of Anesthesiologists) I-III adult patients with prostate cancer and benign prostate diseases scheduled for robotic surgery at Koç University Hospital.
排除标准
- •<18 years of age
- •ASA (American Society of Anesthesiologists) IV, V patients
- •Non-elective emergency cases
- •Previous major abdominal/pelvic surgery
- •History of significant psychiatric disorders
- •Patients who may have contraindications to nerve blocks (bleeding diathesis, infection, and local anesthetic allergy).
研究组 & 干预措施
Preoperative RSB Group
The group of patients undergoing robotic prostatectomy surgery who received a rectus sheath block prior to the surgical procedure
干预措施: Early bilateral rectus sheat block (Procedure)
Postoperative RSB Group
The group of patients undergoing robotic prostatectomy surgery who received a rectus sheath block after the surgical procedure
干预措施: Late bilateral rectus sheat block (Procedure)
结局指标
主要结局
Total intraoperatif remifentanil consumption
时间窗: Total operative duration
Average intraoperative remifentanil consumption
时间窗: Total operative duration
Total intraoperative remifentail consumption divided by the weight of the patient (kg) and total operative duration (minutes). (mcg/kg/dk)
次要结局
- Cumulative opioid consumption at postoperative 1st hour(From the end of the surgery to the end of the first postoperative hour)
- Cumulative opioid consumption at postoperative 6th hour(From the end of the surgery to the end of the 6th postoperative hour)
- Cumulative opioid consumption at postoperative 12th hour(From the end of the surgery to the end of the 12th postoperative hour)
- Cumulative opioid consumption at postoperative 24th hour(From the end of the surgery to the end of the 24th postoperative hour)
- Pain at postoperative first hour(At the end of the postoperative 1st hour)
- Pain at postoperative 6th hour(At the end of the postoperative 6th hour)
- Pain at postoperative 12th hour(At the end of the postoperative 12th hour)
- Pain at postoperative f24th hour(At the end of the postoperative 24th hour)
- Rescue analgesia(From the end of the surgery to the end of the first postoperative hour)
- Patient satisfaction(At the end of the 24th postoperative hour)
研究者
Rafet Onur Gorgulu
Rafet Onur Gorgulu, MD, Resident of Anesthesiology and Reanimation, Department of Anesthesiology, Koc University Hospital
Koc University Hospital