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临床试验/NCT03887260
NCT03887260Unknown不适用

Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/NSS Performed Via Lumbotomy

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
42
试验地点
1
主要终点
Postoperative Morphine Requirements

研究概览

简要总结

42 patients age of 20 to 85, (ASA) physical status I-III undergoing nephrectomy/NSS procedures via lumbotomy in 1st Department of Anesthesiology in Warsaw will be enrolled in the study. Patients will be randomised into 2 groups - patients from the first group will undergo General Anesthesia (GA) with intravenous analgesia peri-operatively, patients from the second group will receive GA plus the Erector Spinae Plane Block (ESP block) unilaterally performed under ultrasound guidance with catheter left on the side of surgery. Ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the Th7 spinous process. Three muscles will be identified superficial to the hyperechogenic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 18-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip gets in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. . Patients in this group will be anesthetized with 20ml 0,25% bupivacaine + Adrenaline 1:200 000 via interfascial catheter. ESP block will be performed at the level of Th7-8 after proper positioning he patient in the sitting position before GA then standard technique of catheter application will be applied. After the surgery the elastomeric pump will be attached to the catheter with 0,125% bupivacaine with Adrenaline 1:200 000. Anaesthesia will be standardised In the both groups.

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
None

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pts undergoing nephrectomy/NSS procedures via lumbotomy in 1st Department of Anaesthesiology in Warsaw
  • Pts consented for the study prior to surgery

排除标准

  • Pts without consent for trial
  • Pts ASA 4-5
  • Coagulation abnormalities
  • Allergy to local anesthetics
  • Skin lesions in the place of needle insertion

研究组 & 干预措施

GA group

Active Comparator

Patients will receive general anaesthesia for nephrectomy/NSS procedures via lumbotomy. Analgesia will be provided by titration of fentanyl during surgery. An intravenous patient controlled morphine pump will be used postoperatively.

干预措施: Morphine PCA pump (Drug)

GA group

Active Comparator

Patients will receive general anaesthesia for nephrectomy/NSS procedures via lumbotomy. Analgesia will be provided by titration of fentanyl during surgery. An intravenous patient controlled morphine pump will be used postoperatively.

干预措施: Fentanyl (Drug)

ESP group

Experimental

Patients will receive general anaesthesia with ESP block for nephrectomy/NSS procedures via lumbotomy. Catheter will be inserted in the erector spinae plane on the side of surgery. Postoperatively patients will get continuous infusion of 0,125% Bupivacaine+Adrenaline to the catheter for 24h and PCA morphine pump intravenously.

干预措施: Morphine PCA pump (Drug)

ESP group

Experimental

Patients will receive general anaesthesia with ESP block for nephrectomy/NSS procedures via lumbotomy. Catheter will be inserted in the erector spinae plane on the side of surgery. Postoperatively patients will get continuous infusion of 0,125% Bupivacaine+Adrenaline to the catheter for 24h and PCA morphine pump intravenously.

干预措施: ESP block (Procedure)

ESP group

Experimental

Patients will receive general anaesthesia with ESP block for nephrectomy/NSS procedures via lumbotomy. Catheter will be inserted in the erector spinae plane on the side of surgery. Postoperatively patients will get continuous infusion of 0,125% Bupivacaine+Adrenaline to the catheter for 24h and PCA morphine pump intravenously.

干预措施: Fentanyl (Drug)

结局指标

主要结局

Postoperative Morphine Requirements

时间窗: 24 hours post surgery

Patient Controlled Analgesia (PCA) morphine consumption in both groups will be recorded.

次要结局

  • Intraoperative Fentanyl Requirements(Time of surgery.)
  • Postoperative Nausea and Vomiting (PONV) PONV PONV(24 hours post surgery)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (1)

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