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临床试验/NCT06215053
NCT06215053
已完成
不适用

The Effect of Erector Spinal Area (Esp) Block Applied Before or After Surgery on Postoperative Acute Pain and Quality of Recovery in Patients Undergoing Spinal Surgery

Aydin Adnan Menderes University2 个研究点 分布在 2 个国家目标入组 46 人2024年1月1日

概览

阶段
不适用
干预措施
erector spine plane block
疾病 / 适应症
Opioid Use
发起方
Aydin Adnan Menderes University
入组人数
46
试验地点
2
主要终点
opioi consumption
状态
已完成
最后更新
19天前

概览

简要总结

Spinal surgery patients generally have chronic pain in the preoperative period and are exposed to widespread and severe acute pain postoperatively. In spinal surgery patients, providing postoperative analgesia is important not only for the patient's comfort but also for preventing the negative effects of pain on the systems, allowing early mobilization, reducing hospital stay and especially reducing chronic pain syndrome.

Although ESP block is routinely used in spinal analgesia, the answer to the question of whether investigators should perform the block after putting the patient to sleep or before waking the patient after completing the surgery is not clear. Preference varies among anesthesiologists.YOU investigators propose a randomized double-blind study comparing patients who underwent ESP block before surgery (Group 1) with patients who underwent ESP block after surgery (Group 2).

详细描述

investigators propose a randomized double-blind study comparing patients who underwent ESP block before surgery (Group 1) with patients who underwent ESP block after surgery (Group 2). Blind patients and postoperative follow-ups will not know which group the patient is in the study. The study will be conducted at Adnan Menderes University hospital with the approval of the ethics committee and the written consent of the patients. The study will be registered on the ClinicalTrials.gov website before the first patient is enrolled. Preoperative Visit Documentation of eligibility and consent will be confirmed at the preoperative visit. During this visit, patients will provide demographic and historical medical information, including information regarding medication use. They will fill out the QR-40 quality compilation survey form. intraoperative The clinic's routine anesthesia protocol will be applied to the patient. Anesthesia will not be interfered with. Group 1: Following induction of anesthesia, ESP block will be performed before the surgery begins, Group 2: ESP block will be performed before waking the patient at the end of surgery. Postoperative The peroperative analgesia plan will be applied the same to all patients. In this protocol, intravenous paracetamol was determined as 1 g and tramadol was determined as 1 mg/kg. Then it is paracetamol every eight hours and tramadol from PCA. At the end of the operation, patients' pain levels will be determined and recorded with the Numeric Rating Scale (NRS) system at postoperative intervals. The quality of recovery (QoR-40) of both groups of patients at the 24th postoperative hour will be evaluated with a scoring system.

注册库
clinicaltrials.gov
开始日期
2024年1月1日
结束日期
2025年2月26日
最后更新
19天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Aydin Adnan Menderes University
责任方
Principal Investigator
主要研究者

SINEM SARI

anesthesiologist

Aydin Adnan Menderes University

入排标准

入选标准

  • Spinal surgery performed under elective conditions
  • ASA I-III 3.18-75 years old

排除标准

  • Rejection during registration
  • Request for dismissal from employment
  • Inability 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
  • Presence of infection at the injection site

研究组 & 干预措施

group 2

An ESP block will be performed before waking the patient at the end of surgery.

干预措施: erector spine plane block

group 1

Following induction of anesthesia, ESP block will be performed before the surgery begins

干预措施: erector spine plane block

结局指标

主要结局

opioi consumption

时间窗: 24 hours

Postoperative 30th minute, 1st, 6th, 12th, 18th. Patients' opioid consumption on the PCA will be recorded at the 24th and 24th hours.

次要结局

  • nrs(24 hours)
  • recovery(24 hours)

研究点 (2)

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