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临床试验/NCT04112394
NCT04112394已完成不适用

Evaluation of Postoperative Pain and Recovery Quality (QoR-40) in Patients Undergoing Erector Spinal Area (ESP) Block After Laparoscopic Cholecystectomy

Konya Meram State Hospital1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2019年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
Quality of Recovery (QoR-40) score

研究概览

简要总结

The primary aim of this prospective, randomized study is to evaluate the effect of erector spinae block (ESP) on quality of recovery with the QoR-40 questionnaire in patients undergoing elective laparoscopic cholecystectomy.

详细描述

Laparoscopic cholecystectomy, one of the most common general surgical procedures, is the gold standard for the treatment of symptomatic gallbladder diseases. Although it is considered as minimally invasive surgery, pain in the early postoperative period is still meaningful. Proper pain control is essential for optimizing clinical outcomes and earlier ambulation after surgery. Traditional pain management with opioids provide good pain control, however, have undesirable side effects such as nausea, vomiting, and respiratory depression. Multimodal analgesia strategies with different classes of analgesics or local anesthetics may enhance pain relief and reduce side effects after surgery. The ESP a newer regional nerve blockade, has been used as part of a multimodal strategy to optimize postoperative pain control. The primary aim of this study is to evaluate the effect of ESP block on postoperative recovery quality in patients undergoing laparoscopic cholecystectomy with QoR-40 recovery questionnaire. Secondary aim is to assess the effect of ESP block on postoperative pain, nausea, and vomiting.

Study hypothesize is that patients who receive an ESP block in addition to the current standard of care, consisting of parenteral opioids and paracetamol, will have a clinically significant improvement in their QoR-40 at postoperative day 1 and lower pain levels, as measured by NRS in comparison to those patients who receive the current standard of care along.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiology (ASA) physical status I-II
  • Scheduled for elective laparoscopic cholecystectomy

排除标准

  • a history of allergy to local anesthetics
  • known coagulation disorders
  • infection near the puncture site
  • Chronic opioid intake
  • Patient with psychiatric disorders
  • inability to communicate

结局指标

主要结局

Quality of Recovery (QoR-40) score

时间窗: postoperative 24 hour

QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200.

次要结局

  • Postoperative pain: numeric rating scale (NRS)(Postoperative 24 hours)
  • Analgesic consumption(Postoperative 24 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Betul Kozanhan

Ass.Prof.

Konya Meram State Hospital

研究点 (1)

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