Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy: A Prospective, Randomized, Controlled, Single Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Dosage of Drugs
研究概览
简要总结
Investigators' goal is to determine whether Erector Spinae Plane Block would provide a better analgesia, help mobilization and early discharge or increase satisfaction for patients undergoing Percutaneous Nephrolithotomy(PNL).
One of the two groups will receive ESP catheterization after general anesthesia conducted. The other group will receive routine analgesia protocol used for PNL.
The total amount of drugs administered, pain scores(NRS) at certain time intervals and at certain events(removal of nephrostomy and pain at mobilization) will be recorded and compared.
详细描述
Erector Spinae Plane Block(ESP) is a rather new method which can block ventral and dorsal rami of spinal nerves in the paravertebral area after they leave the spinal column. Originally used for thoracic somites, by spreading in a craniocaudal fashion in the erector spinae muscle group, it has the potential of blocking cervical or lumbar nerves as well.
To provide better analgesia for surgical procedures, anesthesiologists use truncal blocks for peripheral intervention. Although these blocks are generally very effective and easy to apply, they are limited by a relatively small area of effectivity. In order to achieve denser effects for larger surfaces, epidural anesthesia must be used with the risk of more severe complications than any peripheral or truncal nerve blocks. Epidural anesthesia also has the disadvantages of requiring more experience and more cautiousness than ultrasound-guided truncal blocks and risks of an undesirable temporary motor blockade. ESP block could be the answer for better regional analgesia while avoiding motor blockade and complications of epidural anesthesia.
The study will have two groups as Block Group(GB) and Control Group(GC) and two periods as during operation and 48 hours after the operation. Every participant will receive Total Intravenous Anesthesia(TIVA) and will be monitored with ECG, non-invasive blood pressure, heart rate, pulse oximeter, and Bispectral Index. Participants in GB will receive ultrasound-guided ESP block catheter after proper maintenance of anesthesia provided. The first period will be during operation. We will evaluate the administered drug amounts per kilogram for each patient. Investigators believe ESP block will help them deliver proper anesthesia with lower dosages. The second period will include postoperative 48 hours. Pain scores(NRS) will be evaluated at certain time intervals and at two critical moments between the two groups. One of the critical moment which patients fear and feel the pain most is the removal time of nephrostomy. The second moment is the first time patients start walking.
Rescue analgesia will be ordered on demand for both groups as IV 1 mg/kg tramadol. Hours and amounts of rescue analgesia administered will be recorded.
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
- Single (Care Provider)
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
- •Patients who are scheduled for percutaneous nephrolithotomy under total intravenous anesthesia
- •Patients who has informed consent for study
- •Patients with American Society of Anesthesiologists Physical Status Classification(ASA) I and II
排除标准
- •Patient's refusal to participate
- •Patients under 18 years of age
- •Patients who are undergoing surgery with an anesthesia technique other than total intravenous anesthesia for any reason (inhalation anesthesia, laryngeal mask application, etc.)
- •Patients with known local anesthetic allergy
- •Patients with Body mass index > 35
- •Patients diagnosed sepsis and bacteriemia,
- •Skin infection at the injection site,
- •Patients with previous spinal surgery
- •History of coagulopathy or anticoagulant therapy
- •Patients with uncontrolled diabetes ,
- •Uncoordinated patients,
- •Psychological and emotional lability,
- •Surgical intervention longer than 3 hours.
研究组 & 干预措施
GBlock
Ultrasound Guided Erector Spinae Plane Block Catheter will be applied: 20ml Bupivacaine 0.25% Injectable Solution* will be administered initially.
20 ml Bupivacaine %0.25 Injectable Solution** will be administered 30 minutes before ambulation at postoperative day(POD) 0 and before removal of nephrostomy at POD 2
*10ml %0,5 Bupivacaine will be diluted with 10ml Saline solution.
干预措施: Ultrasound Guided Erector Spinae Plane Block Catheterisation (Procedure)
GBlock
Ultrasound Guided Erector Spinae Plane Block Catheter will be applied: 20ml Bupivacaine 0.25% Injectable Solution* will be administered initially.
20 ml Bupivacaine %0.25 Injectable Solution** will be administered 30 minutes before ambulation at postoperative day(POD) 0 and before removal of nephrostomy at POD 2
*10ml %0,5 Bupivacaine will be diluted with 10ml Saline solution.
干预措施: Bupivacaine 0.25% Injectable Solution (Drug)
结局指标
主要结局
Dosage of Drugs
时间窗: During procedure
Amounts of drugs per kilogram per hour will be recorded
Post-operative pain assessed by Numeric Rating Scale (NRS)
时间窗: At the time of removal of nephrostomy at postoperative day (POD) 2
Pain scores will be recorded during the procedure as reported by the patient according to NRS
次要结局
- Opioid Consumption(48 hour post-operatively)
- Discharge(240 hours post-operatively)
研究者
Mehmet Uğur Bilgin
Anesthesiology Resident
Bozyaka Training and Research Hospital