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临床试验/NCT07621744
NCT07621744已完成不适用

Determination of the Effect of Parasternal Block Versus Wound Site Infiltration on Postoperative Pain Levels by Salivary Opiorphin Levels in Patients Undergoing Median Sternotomy: A Randomized Prospective Study

Ataturk University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1

研究概览

简要总结

This study evaluated the effects of parasternal block and wound site infiltration on postoperative pain in patients undergoing median sternotomy. Patients were allocated to receive parasternal block, wound site infiltration, or standard systemic analgesia. Salivary opiorphin levels and postoperative pain scores were assessed to compare analgesic effectiveness between the groups.

详细描述

This randomized prospective study included patients undergoing surgery through median sternotomy. The study compared three perioperative analgesic approaches: parasternal block, wound site infiltration, and standard systemic analgesia without local intervention at the surgical site.

Salivary samples were collected before surgery, after sternotomy, and during the postoperative period to measure opiorphin levels. Postoperative pain was assessed using visual analogue scale scores, and additional analgesic requirement, opioid consumption, extubation time, intensive care unit stay, and adverse effects such as nausea and vomiting were recorded.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants and postoperative outcome assessors were blinded to group assignment. In addition, laboratory personnel performing salivary opiorphin measurements were blinded to treatment allocation.

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for surgery through median sternotomy
  • Patients who provided informed consent

排除标准

  • Age under 30 years
  • Presence of ischemic, inflammatory, or systemic disease, except cardiovascular disease
  • Use of analgesic medication within the last 24 hours
  • Diagnosis of psychiatric disorder
  • Presence of any oral pathology, including active dental caries, aphthous lesions, or salivary gland inflammation
  • Prolonged intubation or inability to be separated from mechanical ventilation for more than 8 hours

研究者

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

Mehmet Akif Yilmaz

Principal Investigator

Ataturk University

研究点 (1)

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