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临床试验/NCT05428982
NCT05428982已完成不适用

The Effect of Postoperative Modified Trendelenburg Position to Decrease Shoulder Pain After Laparoscopic Hysterectomy: A Randomized Controlled Trial

Rajavithi Hospital2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Comparison of shoulder pain score

研究概览

简要总结

Laparoscopic surgery is commonly used procedure in diagnostic and treatment including Hysterectomy. Post laparoscopic shoulder pain is common side effect mostly occur after surgery. Postoperative Trendelenburg position might decrease pain by reducing the mechanical pressure of CO2 on the diaphragm. Maintaining the patient in Trendelenburg for 6 hours postoperatively will decrease postoperative shoulder pain.

详细描述

After laparoscopic hysterectomy surgery, Patients in intervention group were positioned in a Modified Trendelenburg position (20 °) postoperative for 6 hours because of the limitation of this study cannot positioned in Trendelenburg position.

A modified Trendelenburg position is head and trunk of patient were in neutral position while hips and lower extrimities were raised at 20 degree.

In control group were in neutral position. All patients were asked shoulder pain score at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours

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
None

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patient age between 30-65 years
  • American Society of Anesthesiologist (ASA) physical status I or II
  • Scheduled for operative laparoscopic hysterectomy with abdominal incisions measuring less than 1 cm in size
  • Can speak and understand Thai language

排除标准

  • Pregnant women
  • Conversion procedure to open abdominal surgery
  • Patients with postoperative abdominal drainage
  • Surgery duration more than 3 hours
  • Gynecologic malignancy surgery
  • Patients with history of chronic shoulder pain
  • Patients with history of previous shoulder surgery
  • Inability to accurately express pain
  • Patients with history of Gastroesophageal reflux disease or chronic gastritis
  • Patients with history of cardiovascular or pulmonary disease
  • Patients with history of venous thrombosis
  • Morbid obesity BMI > 40 kg/m2
  • Patients with history of increase intracranial pressure
  • Patients with history of increase intraocular pressure
  • Patients with liver and/or kidney disease
  • NSAIDs and/or Paracetamol and/or Morphine allergy
  • Current corticosteroid use
  • Patients who use current analgesic drugs and don't want to quit while stay in the hospital
  • Psychiatric disorder
  • Intellectual disorder
  • Postoperative length in hospital less than 24 hours

结局指标

主要结局

Comparison of shoulder pain score

时间窗: at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours

Comparison of shoulder pain score at 6 hours after postoperative Modified Trendelenburg position for 6 hours Using Numerical rating scale 0-10, 0 mean no pain, 10 mean worst pain

次要结局

  • Comparison of upper abdominal pain score(at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours)
  • Comparison of nausea vomiting score(at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours)
  • Comparison of lower abdominal pain score(at ward, 6 , 12, 24 hours after postoperative Modified Trendelenburg position for 6 hours)
  • Total amount of antiemetic drugs in 24 hours postoperatively(24 hours postoperatively)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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