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临床试验/NCT05792124
NCT05792124招募中不适用

Comparison of the Effects of Retro Laminar Block (RLB) and Erector Spina Area Block (ESP) on Postoperative Recovery Quality and Pain in Lumbar Spinal Surgery

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
Qor-40 test (The recovery quality test)

研究概览

简要总结

The aim of this study is to compare the efficacy of erector spinae plane block (ESPB) and Retrolaminar Block on postoperative recovary quality and pain after lumbar spinal surgery

详细描述

The study was designed as a double-blind, prospective randomized controlled trial.

Blindness; The healthcare professionals who will monitor the patient's pain in the post-operative period will not know which of the ESP or RLB block is applied. Randomization of the patients was planned using computer aided. It was envisaged to include 40 participants each in the ESP block and RLB block groups. The current pain status of the patients in the ESP block and RLB block groups in the postoperative period was determined by NRS (Numerical rating scale) at rest and motion at certain hour intervals (30 .min,1.,6.,12.,24. hours) will be done, when the patients' NRS scores are 4 and above, an additional intravenous analgesic will be administered and the number of bolus doses with PCA in the first 24 hours will be recorded. The recovery quality of the patients who underwent both ESP block and RLB block at the postoperative 24th hour will be evaluated with a (QoR-40) scoring system. In addition, the hemodynamic values of the patients will be recorded in these intervals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

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

  • Patients undergoing lumbar spinal surgery under elective conditions
  • ASA I-III
  • Between 18-75 ages

排除标准

  • refuse during registration
  • request to be dismissed from study
  • failure to give informed consent
  • emergency surgery
  • bleeding diathesis
  • Presence of contraindications to the LA agents used in this study chronic use of opioids psychiatric disorders the presence of infection at the injection site

结局指标

主要结局

Qor-40 test (The recovery quality test)

时间窗: 24th hour

For this purpose, patients will be subjected to the Short Form-40- test, which is a short scale of postoperative recovery quality at first 24th hour.Minimum score is 40=bad ,maximum score is 200=good

次要结局

  • NRS (Numerical rating scale)(30 minutes,1st hour,6th hour,12th hour and 24th hour)
  • Postoperative pain(30 minutes,1st hour,6th hour,12th hour and 24th hour)

研究者

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

SINEM SARI

associate professor

Aydin Adnan Menderes University

研究点 (2)

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