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临床试验/NCT03997227
NCT03997227Unknown不适用

Erector Spinae Plane (ESP) Block For Postoperative Pain Management In Lumbar Spine Surgery : A Randomized Control Trial

Aydin Adnan Menderes University2 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2019年5月2日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
68
试验地点
2
主要终点
mobilized , discharged

研究概览

简要总结

Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay.

The aim of this study was to investigate the effect of this field block on postoperative pain and respiratory function in patients undergoing ESP with lomber vertebra surgery and with ultrasound guidance for postoperative analgesia.

详细描述

Lumbar vertebra surgery is one of the most common surgical procedures. After lumbar veretebra surgery, patients complain of excessive pain. Postoperative pain usually occurs in the early postoperative period and delays patient mobilization and thus lengthens hospital stay.

The aim of this study was to investigate the effect of this field block on postoperative pain and respiratory function in patients undergoing ESP with lomber vertebra surgery and with ultrasound guidance for postoperative analgesia.

ASA I-III, 68 patients between 18-75 years of age were planned to be included in the study. 34 participants were expected to be included in the control and implementation group.

In our study, the ESP block was planned to be applied to the patients in the block group. Peroperative analgesia plan will be applied to all patients in the same way. In this protocol, intravenous paracetamol 1 gr and tramadol 1 mg / kg were determined. Then, every eight hours, paracetamol and contromal infusion.

At the end of the operation, the patients will be determined by the Numeric Rating Scale (NRS) system at the 30th hour, 1st, 6th, 12th and 24th hours after the first hour of the operation. Tramadol PCA and paracetamol are administered every eight hours.

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 (Participant)

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

  • 68 patients
  • ASA I-III,
  • Aged 18-75 years
  • underwent lumbar spine surgery under elective conditions

排除标准

  • Presence of contraindications to LA agents used in this study
  • Use of chronic opioids,
  • Psychiatric disorders.
  • Surgical procedures that lasted <60 minutes or> 300 minutes
  • The presence of infection at the injection area.

结局指标

主要结局

mobilized , discharged

时间窗: 7 days

each criterion is reported as when the patient is mobilized and when he is discharged

pruritus, nausea and vomiting, use of antiemetics

时间窗: 24 hours

each criterion is reported as present or absent each criterion is reported as present or absent

NRS(numerical rating scala)

时间窗: 24 hours

Each item is scored 0-10 ( 0=no pain, 10= pain as bad as can be) Postoperative pain intensity reported with NRS score : 30. minute, 1. hours, 6. hours, 12. hours, 24. hours

次要结局

未报告次要终点

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

Sinan ASAR

Principal Investigator, clinical research

Aydin Adnan Menderes University

研究点 (2)

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