Comparison of Thoracic Epidural Analgesia With Ultrasound-Guided Bilateral Erector Spinae Plane Block in Radical Cystectomy Surgery: A Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time for first rescue analgesia
研究概览
简要总结
The aim of this study is to compare between Thoracic Epidural Analgesia (TEA) with ultrasound-guided bilateral erector spinae plane (ESP) block in radical cystectomy surgery for analgesic efficacy and hemodynamic effects
详细描述
The patients will be randomly allocated into two equal groups using a computer program.
Group A: will receive bilateral Erector Spinae Block after induction of anesthesia.
Group B: will receive Thoracic Epidural Block before induction of anesthesia.
The methods:
Preoperative evaluation of each patient will include full history taking, revision of all laboratory investigations and full clinical examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Eligible patients will be older than 40-70 years old with american society of ASA physical anesthesiologist status I, II and III scheduled for elective radical cystectomy surgeries
排除标准
- •Patients who have allergy to any of the study drugs.
- •Patients who are on opioids.
- •Known abuse of alcohol or medication.
- •Local infection at the site of injection or systemic infection.
- •Pregnancy
- •Patients with coagulation disorders or on anticoagulation therapy
研究组 & 干预措施
Erector Spinae Block
after induction of anesthesia bilateral US ESP block will be performed in the left lateral decubitus position under strict aseptic precautions. linear ultrasound transducer will be placed in a sterile cover, and positioned on the midline to identify the T10 spinous process. From this position, the ultrasound transducer will be moved 2-3 cm laterally to visualise the hyperechoic line of the T10 transverse process with its associated acoustic shadow inferiorly, and the overlying erector spinae muscle superiorly. Using in-plane approach a needle will be inserted in caudal-cephalad direction, until the tip is contact with the T10 transverse process and will be in the interfacial plane deep to the erector spinae muscle group and A dose of 30 ml 0.125% Bupivacaine will be injected bilateral in this plane . All patients will receive 1g intravenous paracetamol and 4 grams ondansetron 8mg dexamethasone
干预措施: bilateral Erector spine block,A dose of 30 ml 0.125% Bupivacaine will be injected. (Procedure)
Thoracic Epidural Block
before induction of anesthesia under strict aseptic precautions, 18Gauge Tuohy's needle with Huber's tip will be inserted via median approach after local infiltration with 5 ml of 2% lignocaine at the level of T9-T10 or T10-T11 intervertebral space in the sitting position. After identifying epidural space using loss of resistance technique, 5 ml of saline will be administered after negative aspiration for blood or cerebrospinal fluid and 20Gauge epidural catheter will be threaded 5 cm cranially.
the patients in group B will be administered with a bolus dose of 10 ml of 0.125% bupivacaine through epidural catheter followed by continuous infusion of 0.125% bupivacaine at the rate of 0.1 ml/kg/hour All patients will receive 1g intravenous paracetamol and 4 grams ondansetron 8mg dexamethasone
干预措施: Thoracic epidural analgesia (Procedure)
结局指标
主要结局
Time for first rescue analgesia
时间窗: 24 hours
the time of request of the patient of analgesia wil be recorded
次要结局
- the number of rescue analgesics within 24hrs after surgery(24 hours)
- Visual analogue scale score at 1st,2nd,4th,6th,8th,12th and 24 h (where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain)(24 hours)
研究者
Amal Gouda Elsayed Safan
lecturer of anaethesia
Menoufia University