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临床试验/NCT06172920
NCT06172920尚未招募4 期

Comparison of the Analgesic Effects of Tramadol, Pethidine and Morphine Under Erector Spinae Plane (ESP) Block in the Treatment of Pain After Elective Thoracic Surgery

Baskent University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年12月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
45
试验地点
1
主要终点
Comparing hemodynamic effects

研究概览

简要总结

Comparison of analgesic effects of tramadol, aldolan and morphine under thoracic surgery

详细描述

Thoracotomy is one of the most painful surgical procedures known, and severe pain is encountered in 21-67% of patients after thoracotomy. The most important causes of this pain arise from the bone structures of the thoracic wall, damage to the costal joint junctions, stretching of the ligaments, rib fractures, and damage to the intercostal nerve and major muscles. Another factor that causes pain after thoracotomy is the chest tubes placed in the thorax to provide drainage (1).

As a result of this pain caused by loss of tissue and pulmonary reserve, effective coughing and decreased chest expansion can lead to serious complications such as atelectasis, ventilation/perfusion mismatch, hypoxemia, immobilization, thromboembolism and infection. These complications are associated with increased morbidity and mortality in thoracic surgery (2).

Ensuring pain management in patients undergoing thoracotomy is important in terms of reducing postoperative complications, ensuring early mobilization and increasing patient comfort. Since there is no single source that causes pain after thoracotomy, pain must be controlled at all levels. For this reason, a multimodal approach using pharmacological and non-pharmacological techniques is preferred in analgesia after thoracotomy. This approach reduces drug side effects along with the consumption of analgesics. Opioids and nonsteroidal anti-inflammatory drugs are used in pharmacological analgesia.

In our study, the investigators aim to compare the effects of tramadol, pethidine and morphine using intravenous patient-controlled analgesia in the treatment of postoperative pain in elective thoracic surgery.

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, Care Provider)

盲法说明

Double blind

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having non-urgent thoracic surgery
  • over 18 years old
  • Being in group I-III according to the American Society of Anesthesiologists (ASA) classification
  • Not have allergies to the drugs to be used (volunteers with diseases that prevent the use of drugs will not be included in the study
  • regardless of gender

排除标准

  • . Have allergies to the drugs to be used

研究组 & 干预措施

Morphine

Active Comparator

Morphine receiving group

干预措施: Morphine hydrochloride (Drug)

Tramadol

Active Comparator

Tramadol receiving group

干预措施: Tramadol hydrochloride (Drug)

Aldolan

Active Comparator

Aldolan receiving group

干预措施: Aldolan (Drug)

结局指标

主要结局

Comparing hemodynamic effects

时间窗: Intraoperatively, then postoperative 24 hours

To compare hemodynamic effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery, It will be asssesed with measurements of intraoperative values of systolic, diastolic and mean arterial blood pressure

Comparing respiratory effects

时间窗: postoperative 24 hours

To compare respiratory effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery. It will be asssesed with postoperative pulmonary complications such as failed extubation, bronchospasms or respiratory depressions.

The rate of drugs's analgesic effects

时间窗: postoperative 24 hours

To compare the analgesic effects of tramadol, pethidine and morphine in the treatment of postoperative pain in thoracic surgery, It will be assesed with numeric rating scale ( 0= no pain, 10= worst pain imaginable)

次要结局

  • surgeon satisfaction(Immediately after the surgery)
  • Adverse effects of analgesics(postoperative 24 hours)
  • patient satisfaction(Postoperative 30th minute)

研究者

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

Begüm Nemika Gökdemir

Begüm Nemika Gökdemir, Research Assistant of Anesthesiology Department

Baskent University

研究点 (1)

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