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临床试验/NCT07547124
NCT07547124尚未招募不适用

Association Between Postoperative Analgesic Approaches and Quality of Recovery and Swallowing Pain in Patients Undergoing Elective Total Thyroidectomy: A Prospective Observational Study

Istinye University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Quality of Recovery-15 (QoR-15) Total Score

研究概览

简要总结

This prospective observational study evaluates the association between postoperative analgesic approaches and recovery outcomes in patients undergoing elective total thyroidectomy. Patients will be followed under routine clinical care without intervention or randomization.

The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours. Secondary outcomes include swallowing pain, resting pain, opioid consumption, postoperative nausea and vomiting, and additional analgesic requirement.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Patients aged 18-75 years
  • ASA physical status classification I-III
  • Patients scheduled for elective bilateral total thyroidectomy
  • Patients undergoing surgery under general anesthesia
  • Individuals able to read and understand Turkish and cognitively capable of completing the QoR-15 questionnaire
  • Patients providing written informed consent to participate in the study

排除标准

  • Chronic opioid use (≥3 months of regular opioid use)
  • Presence of chronic pain syndrome
  • Psychiatric illness or cognitive impairment
  • History of neurological disease (stroke, dementia, Parkinson's disease, etc.)
  • Known allergy to local anesthetic agents
  • Previous surgical interventions in the cervical region (including revision thyroid surgery)
  • Planned extended surgery with concomitant neck dissection
  • Substernal/retrosternal goiter cases (with potential need for sternotomy or additional procedures)
  • Emergency surgical procedures
  • Patients with ASA physical status IV or higher
  • Pregnancy
  • Patients expected to require postoperative intensive care
  • Patients experiencing intraoperative complications that deviate from the standard monitoring protocol

研究组 & 干预措施

Cervical Plexus Block Group

Patients who receive bilateral intermediate cervical plexus block as part of routine clinical practice, based on the attending anesthesiologist's decision.

No Block Group

Patients who do not receive cervical plexus block and are managed with standard postoperative analgesia according to routine clinical practice.

干预措施: Cervical Plexus Block (Other)

结局指标

主要结局

Quality of Recovery-15 (QoR-15) Total Score

时间窗: 24 hours postoperatively

Quality of recovery will be assessed using the QoR-15 questionnaire. The total score ranges from 0 to 150, with higher scores indicating better recovery. The outcome will be compared between patients who received cervical plexus block and those who did not.

次要结局

未报告次要终点

研究者

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

İlke Dolgun

Assoc.Prof

Istinye University

研究点 (1)

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