Ultrasound Guided Bilateral Erector Spinae Plane Block in Retropubic Radical Prostatectomy
Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Retropubic Radical Prostatectomy Patients; Randomised, Controlled Prospective Study
研究概览
详细说明
Open retropubic prostatectomy is a surgical method that is applied in cases of benign prostatic hypertrophy and prostate cancer which is not suitable for surgical treatment with closed method. This method is commonly used among urological procedures which are open surgical procedures. Patients after this procedure often complain of excessive pain. Non-steroidal anti-inflammatory agents and opioids are used for postoperative analgesia. In addition, in the past decade, in the guideline of ultrasonography, peripheral block types have been described that demonstrate analgesic activity in open prostatectomies as well as many operations on the development of regional anesthesia and analgesia techniques. The ultrasonography guideline reported that the transverse abdominal plane (TAP) block provides effective analgesia in these cases. The ESP block is a new block for the treatment of thoracic neuropathic pain. In the following process; ESP block thoracic and breast surgery, bariatric surgery, and upper abdominal surgeons have also been reported to provide effective postoperative analgesia.
The standard practice for post-operative pain management for retropubic radical prostatectomy in Maltepe University Hospital consists of routine intravenous analgesic and rescue analgesics and in combination with patient-controlled analgesia (PCA).
The application of erector spinae plane (ESP) block technique under ultrasonography guideline under sedoanalgesia in patients who will undergo retropubic prostatectomy with open method should determine the effect on the patient's pain level in the first 24 hours after operation.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Feyzullah No:39
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Istanbul、Feyzullah No:39、火鸡、34843
- Maltepe University Medical Faculty
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Elective retropubic radikal prostatectomy, ASA status 1-2
Exclusion Criteria:
- Patient refusal
- Contraindications to regional anesthesia
- Known allergy to local anesthetics
- Bleeding diathesis
- Use of any anti-coagulants
- Inability to provide informed consent
- Severe kidney or liver disease
- Inability to operate PCA system
- Patient with psychiatric disorders
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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假比较器:control
Peroperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed. Intervention: Other: Standard Pain Followup and Monitorization |
数字评定量表 (NRS) 疼痛评分将从恢复室的第 20 分钟开始记录,然后是 1.-3.-6.-12.-18.-24.小时。
术后收集室NSR评分6分及以上的患者确定静脉给予度冷丁0.5 mg/kg抢救镇痛。
计划让患者在病房内继续追踪每小时的 NRS 评分。
如果NRS评分为6分,在此期间肌肉注射双氯芬酸,超过2小时后,如果NRS评分为6分以上,则静脉注射0.5mg/kg度冷丁。
将详细记录抢救镇痛药的需求和时间,并将抢救镇痛药的使用情况以及指定时间的 NRS 评分保存在统计评估中。
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实验性的:ESP block
In addition to routine analgesic protocol; before anaesthesia induction; bilateral ultrasound guided erector spinae plane block (ESP) (intervention) will be performed via USG guidance at Th9 level.Standard Pain Followup and Monitorization will be performed. Interventions: Procedure: Ultrasound guided erector spinae plane block Other: Standard Pain Followup and Monitorization |
数字评定量表 (NRS) 疼痛评分将从恢复室的第 20 分钟开始记录,然后是 1.-3.-6.-12.-18.-24.小时。
术后收集室NSR评分6分及以上的患者确定静脉给予度冷丁0.5 mg/kg抢救镇痛。
计划让患者在病房内继续追踪每小时的 NRS 评分。
如果NRS评分为6分,在此期间肌肉注射双氯芬酸,超过2小时后,如果NRS评分为6分以上,则静脉注射0.5mg/kg度冷丁。
将详细记录抢救镇痛药的需求和时间,并将抢救镇痛药的使用情况以及指定时间的 NRS 评分保存在统计评估中。
A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to T9 spinous process.
The erector spinae muscles will be identified superficial to the tip of T9 transverse process.
The patient's skin will be anesthetized with 2% lidocaine.
A 17-gauge 8-cm needle will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle.
The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process.
A total of 30 mL of 0.375% bupivacaine will be injected (maximum of 3mg/kg).
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Changes in Numeric Rating Scale (NRS)
大体时间:24 hours
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Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals.
NRS is a unidimensional measure of pain intensity in adults.
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g.
"no pain") to '10' representing the other pain extreme (e.g.
"pain as bad as you can imagine" or "worst pain imaginable").
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24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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镇痛药用量
大体时间:24小时
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患者自控镇痛装置中曲马多的用量及附加和抢救镇痛使用
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24小时
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合作者和调查者
调查人员
- 学习椅:ozgur senturk, ass prof、Maltepe University Faculty of Medicine
出版物和有用的链接
一般刊物
- Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Restrepo-Garces CE, Chin KJ, Suarez P, Diaz A. Bilateral Continuous Erector Spinae Plane Block Contributes to Effective Postoperative Analgesia After Major Open Abdominal Surgery: A Case Report. A A Case Rep. 2017 Dec 1;9(11):319-321. doi: 10.1213/XAA.0000000000000605.
- Elkassabany N, Ahmed M, Malkowicz SB, Heitjan DF, Isserman JA, Ochroch EA. Comparison between the analgesic efficacy of transversus abdominis plane (TAP) block and placebo in open retropubic radical prostatectomy: a prospective, randomized, double-blinded study. J Clin Anesth. 2013 Sep;25(6):459-65. doi: 10.1016/j.jclinane.2013.04.009. Epub 2013 Aug 17.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Maltepe University
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计划共享个人参与者数据 (IPD)?
IPD 计划说明
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