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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 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
2
主要终点
opioi consumption

研究概览

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.

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)

盲法说明

Blind patients and postoperative follow-ups will not know which group the patient is in the study

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

  • 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

Other

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

干预措施: erector spine plane block (Other)

group 1

Other

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

干预措施: erector spine plane block (Other)

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

anesthesiologist

Aydin Adnan Menderes University

研究点 (2)

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Pre-post Erector Spine Plane Block-spinal Surgery | 临床试验