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临床试验/NCT05299788
NCT05299788已完成不适用

The Effectiveness of Active External Warming of Patient Concurrently With Ice Application on the Incision Site on Post-thoracotomy Pain and Analgesic Consumption

Akdeniz University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年1月15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
入组人数
70
试验地点
1
主要终点
Body temperature degree

研究概览

简要总结

The aim of study is to investigate the effects of active external warming of patient concurrently with application of ice to incision site on thoracotomy pain and analgesic consumption. The research is a quasi-experimental design with control and study groups.

详细描述

The study was initiated after obtaining the written approval of the study centers. The center of the study and the hospital where the research was conducted. Written permission was obtained from the hospital management. Within the scope of the research, the research was explained to the participants and their consent was obtained.

The routine analgesia protocol was applied to patients in the control group. In addition to the routine analgesia protocol, the study group was administered non-pharmacological pain control interventions comprising active external warming and ice application. In the Intensive Care Unit (ICU), all patients stayed in the same area without a separator so they could easily observe each other's interventions and hear the conversations occurring during medical intervention. For this reason, the control group was evaluated first. After the last patient in the control group was transferred to the clinic, the study group was evaluated.

Active External Warming: In the literature, the use of electric blankets and warm blowing devices were recommended as the best methods for postoperative active external warming.In this study, methods used routinely in the Intensive Care Unit (ICU) such as cotton blankets and socks were used for the control group. In addition to the cotton blankets and socks, electric blankets were used for the patients in the intervention group. In accordance with the literature, the temperature of the electric blanket was set at 38 °C (Celsius) at the beginning and increased to a maximum of 40-41 °C based on the patient's body temperature.

Application of ice to the incision site: Studies have reported that the cooling effect of ice packs is higher than that of cooled gel packs. In the intervention group, an ice pack was applied to the incision site for pain control in addition to active external warming. Ice packs at 0-5 °C with external dimensions of 160 × 91 × 34 mm and a filled weight of 363 g that were kept in the fridge were used for ice application. In this study, ice packs were applied in the first 12 postoperative hours for 20 minutes every 2 hours, and a parallel pain assessment was performed.

Measurements of body temperature, analgesic consumption, and pain level were made to evaluate the effectiveness of active external warming and ice application. The measurements and follow-up of the patients in the study and control groups in the ICU were carried out by these investigators.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

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
否

入选标准

  • •Patients aged between 18 and 65 years who were not underweight or obese (body mass index 19-30 kg/m2)
  • •Patients woke up within the first two postoperative hours, and had been extubated were included in the study group.

排除标准

  • •Patients in whom hemodynamic stabilization was not achieved 2 hours after thoracotomy,
  • •patients with Raynaud's phenomenon, neuropathy, or peripheric vascular disease,
  • •patients who underwent postoperative procedures that directly affect pain levels, such as decortication and thoracic wall resection,
  • •patients who received preemptive analgesia for pain control,
  • •patients who received analgesia through pleural, thoracal, and other catheter methods were excluded from the study.

研究组 & 干预措施

The routine analgesia group

No Intervention

The routine analgesia and warming protocol was applied to patients in the control group.The routine postoperative analgesic treatment protocol at the unit comprises the administration of 75 mg IM (Intramuscular) Diclofenac Sodium before the patient wakes up, 30 mg intravenous (IV) Tramadol if the patient complains of pain when awake (maximum dose of 100 mg/day), and 10 mg/day Morphine Sulfate. In addition to, methods used routinely in the Intensive Care Unit (ICU) such as cotton blankets and socks were used for warming.

The routine analgesia+active external warming+ice application group

Experimental

In addition to the routine analgesia protocol, the study group was administered non-pharmacological pain control interventions.

干预措施: Active external warming (Other)

The routine analgesia+active external warming+ice application group

Experimental

In addition to the routine analgesia protocol, the study group was administered non-pharmacological pain control interventions.

干预措施: Ice application (Other)

结局指标

主要结局

Body temperature degree

时间窗: The patient's body temperature was measured in the first four hours postoperatively

The patient's body temperature was recorded in degrees Celsius.

Pain score

时间窗: Pain scoring was initiated when the patient was extubated and until the postoperative 48th hour were recorded

McGill Pain Questionnaire Short-Form was used for pain assessment. The Verbal Pain Scale, contained in the McGill Pain Questionnaire Short-Form, measured pain intensity at the four-hour mark rating pain of 0 - 5 with 0 = no pain, 1 = mild pain, 2 = discomforting pain, 3 distressing pain, 4 = horrible pain and 5 = excruciating pain.

Analgesic consumption (mg)

时间窗: Analgesic consumption was started to be recorded when the patient was admitted to the intensive care unit, and until the postoperative 48th hour were recorded

Algesic consumption: The analgesic consumption of the patient was evaluated with the analgesics used until the postoperative 48th hour. The amount of analgesic administered to the patient was recorded in milligrams.

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

Emine Kol

Associated Professor

Akdeniz University

研究点 (1)

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