Comparison of Intraoperative and Postoperative Effects of Erector Spinae Plane Block and Rectus Sheath Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- postoperative morphine consumption
研究概览
简要总结
In study, The investigators aimed to compare the intraoperative and postoperative analgesic efficacy of erector spinae plane block and rectus sheath block, which investigators routinely perform in surgeries with abdominal lover midline-upper midline incision, morphine consumption with patient-controlled analgesia, as well as patient and surgeon satisfaction.
详细描述
Following ethics committee approval and written consent from the patients, the study was conducted on 60 patients aged between 18-75 years in American Society of Anesthesiologists (ASA) classes I-III, who were to undergo midline incisions. The demographic data of the patients were recorded and after routine monitoring and general anesthesia induction, they were divided into two groups as the ESPB group and RSB group. Hemodynamic data of all patients were recorded before induction, one minute after induction, and intraoperatively in 30-minute periods. Patient-controlled analgesia (PCA) prepared with morphine was administered to all patients. Patients' intraoperative hemodynamic data and administered opioid doses, postoperative visual analog scales (VAS) at rest and during coughing, time to first PCA dose, postoperative morphine consumption, need for rescue analgesics, duration time until first mobilization, opioid side effects, and patient and surgeon satisfaction were evaluated.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-75 years
- •American Society of Anesthesiologists (ASA) classes I-III
排除标准
- •Local anesthetic allergy
- •Coagulopathy
- •Injection site infection
- •History of abdominal surgery
- •Severe neurological or psychiatric disorder
- •Severe cardiovascular disease, liver failure, renal failure (glomerular filtration rate <15 ml/min/1.73 m2)
- •chronic opioid use
结局指标
主要结局
postoperative morphine consumption
时间窗: 48 hours
Total morphine (mg) consumptions used with postoperative PCA were recorded and compared between groups.
opioid side effects
时间窗: 48 hours
Side effects (nausea, vomiting and sedation) that may occur due to opioid use in patients were recorded. And it was investigated whether there was a difference between the groups.
need for rescue analgesics
时间窗: 48 hours
Bolus-dose morphine administration was provided to patients with VAS ≥4 upon questioning in the clinic or in line with patients' complaints, and patients' VAS scores during the first use of PCA were recorded. It was planned for rescue analgesic to be administered in patients with VAS ≥4 despite PCA, firstly as 20 mg IV tenoxicam (Tilcotil®, Deva, Tekirdağ, Turkey), and secondly as 50 mg IV tramadol (Tramosel®, Haver, Istanbul, Turkey) if VAS was still ≥4 one hour after tenoxicam administration.
postoperative visual analog scales at rest and during coughing
时间窗: 48 hours
Postoperatively, both coughing and resting visual analog scale values (A rating between 0 and 10 was made. 0 no pain 10 severe pain) of the patients were recorded and compared between the groups.
time to first patient controlled analgesia (PCA) dose
时间窗: 48 hours
The times when patients used the PCA device for the first time were recorded and compared between groups.
duration time until first mobilization
时间窗: 48 hours
The times until the first mobilization of the patients were recorded and it was investigated whether there was a difference between the groups in terms of mobilization times.
intraoperative hemodynamic data and administered opioid doses
时间窗: 150 minutes
Intraoperative hemodynamic values (peripheric oxigen saturation, mean arterial pressure, heart rate) of the patients and intraoperative opioid consumption (mg) were compared.
patient and surgeon satisfaction
时间窗: 48 hours
Patient and surgical team satisfaction were recorded using a 5-point Likert scale (A rating of 1 to 5 was requested. 1- not at all satisfied 2- somewhat satisfied 3- undecided 4- satisfied 5- very satisfied).The difference between the groups was investigated.
次要结局
未报告次要终点
研究者
Emre Salman
Principal investigator
Uludag University