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临床试验/NCT04209907
NCT04209907已完成不适用

the Effect of Retrolaminar Block on Post Operative Analgesia After Lumbar Vertebra Surgery

Kırıkkale University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年5月1日最近更新:
适应症

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
change of pain throughout postoperative 24 hours

研究概览

简要总结

In recent years, as a part of multimodal analgesia, paravertebral blocks are replacing epidural analgesia due to the less side effects. Although the risk of pneumothorax is the most feared complication in paravertebral blocks, retrolaminar block (RLB) -which is a paravertebral block- significantly reduces this risk due to the anatomical technique of procedure. The investigators aim to investigate the effect of retrolaminar block with ultrasound- guided on perioperative analgesia for patients undergoing lumbar vertebra surgery.

详细描述

Retrolaminar block will applie before general anesthesia induction when patients will be awake and under midazolam (0.03 mg/kg) sedation and standardized monitoring at the preoperative block area in sitting position using in-plane approach. After sterilising the skin, the investigators will perform block by using 7-18 MHz convex ultrasound probe ( Esaote My Lab 6 US Machine, Florance, Italy) and a 22-gauge, 100-mm Stimuplex needle (B. Braun, Germany). The investigators will pass in a sagittal plane from medial to lateral at the mid-lomber level, and identified the hyperechoic laminae, transverse processes, ribs and pleura.

The L3 laminae will be identified approximately lateral of the spinous process. The needle will insert in-plane, cephalad to caudad. After lamina contact and negative aspiration, 20 ml bupivacaine 0.25% will be injected at low pressure with intermittent negative aspiration on each side and spread of local anesthetic between laminae and paraspinous muscles will be seen without pain or paresthesia. Then 30 minutes later, the patient will be taken to the operating room.

After general anesthesia prosedure, the patients will evaluate whether they have pain throughout 24 hours after the operation. The pain scores will be evaluated with visuel analogue scale.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

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

入选标准

  • 18-75 years old
  • ASA 1, 2, 3 patients
  • undergoing lumvar vertyebra surgery

排除标准

  • pregnant woman
  • patint wiht cognitive disfunction

结局指标

主要结局

change of pain throughout postoperative 24 hours

时间窗: change in postoperative 24 hours

visuel analogue scale is used for post operative pain evaluation. it is range from 0 to 10. 0 is used for no pain, 10 is used severe pain. the investigors will evaluate the postoperative pain with visuel analogue scale

次要结局

未报告次要终点

研究者

发起方
Kırıkkale University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevser Peker

assitant professor

Kırıkkale University

研究点 (2)

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