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临床试验/NCT04739787
NCT04739787Unknown不适用

The Relationships of Regular Preoperative Physical Activities Between Postoperative Pain and Postoperative Nausea and Vomiting on Different Type of Surgeries

Chiayi Christian Hospital0 个研究点目标入组 5,500 人开始时间: 2021年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5,500
主要终点
The effects of physical activities on postoperative pain

研究概览

简要总结

Recommendation is strong on physical activity (PA) in the prehabilitation of Enhanced Recovery After Surgery (ERAS) for various types of surgeries. The evidence is however weak regarding ERAS protocols. Many studies have showed that physical exercise and PA have hypoalgesic effects on healthy individuals and they have better pain tolerance too. Here the investigators study changes in postoperative pain and postoperative nausea and vomiting for various types of surgical patients after performing preoperative PA at moderate or vigorous intensity Vs non-preoperative PA patients.

详细描述

Despite the increasing knowledge on the mechanisms of incisional inflammation, transmission of nociception signals, peripheral and central sensitization, and on top of the current advancements in pharmacology, pharmaceutics, techniques and equipment, unfortunately, the US Institute of Medicine revealed that 80% of patients receiving surgery have reported postoperative pain with 88% of them at moderate, severe, or extreme levels. Opioids for postoperative pain are commonly administered to relieve moderate to severe pain, therefore, the postoperative nausea and vomiting (PONV) incidence will be increased.

ERAS is a prevalent policy that combines evidence-based perioperative care to accelerate surgical recovery, Anesthesiologists are involved in many perioperative ERAS elements of patients in terms of evaluation and implementation: e.g., like prehabilitation via education of physical and core muscles training on the pain management clinic, perioperative multi-modal pain management and multi-modal anti-emetic prophylaxis against PONV.

The overarching aim of multimodal structured prehabilitation programs is to increase, for instance, the cardiopulmonary and musculoskeletal preoperative functional reserve, leading to better postoperative functional recovery and a reduced incidence of complications.

Better ischemic pain tolerance is well documented after combined moderate-and vigorous-intensity aerobic exercise for healthy individuals and acute exercise also has hypoalgesic effects.Unfortunately, these physical activity (PA) researchers have not evaluated specifically effects on postoperative pain and PONV.

The goal of our study is to determine the relationship between preoperative PA on postoperative pain and PONV for different types of surgery, that is, breast neoplasms, thoracic, laparoscopic abdominal, abdominal laparotomy, Ears-Nose-Throat, urinary tract stones and tumors, orthopedic, plastic, spinal and colorectal surgeries.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

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

入选标准

  • aged ≥18 y/o
  • Enrolled in-patients
  • Patients are scheduled to undergo various operations.
  • The surgeries are expected to last ≥60 minutes
  • Endotracheal intubation or laryngeal mask inhalation general anesthesia.

排除标准

  • Patients will transferred to the intensive care unit after operations.
  • American Society of Anesthesiology physical status ≥4
  • poorly controlled diabetic mellitus (HA1c ≥9)
  • prolonged corrected QT interval (male ≥0.45 sec, female ≥0.47 sec)
  • Allergy to any opioids (i.e., morphine, fentanyl, pethidine and others) and nonopioids (i.e., selective or nonselective NSAIDs and acetaminophen)
  • Allergy to dexamethasone, granisetron, droperidol, metoclopramide used for prevention of postoperative nausea and vomiting
  • Deaf or unable to speak/understand Taiwanese or Mandarin
  • Failed to recall or uncertain on how many days/times they had spent doing moderate or vigorous physical activity on recent 6 to 8 weeks before receiving surgery.

结局指标

主要结局

The effects of physical activities on postoperative pain

时间窗: 2 years

Comparison of the effects of physical activity and non-physical activity patients groups on postoperative pain after different types of surgeries. The severity of postoperative pain is measured by using 0-10 Numeric Rating Scale.

The effects of physical activities on postoperative nausea and vomiting

时间窗: 2 years

Comparison of the effects of physical activity and non-physical activity patients groups on postoperative nausea and vomiting (PONV) after different types of surgeries. PONV defined as nausea, vomiting or retching within 24 hours The incidence and severity of PONV are measured by using 5 points Likert Scale (1-5) with 1 represents no any discomfort to 5 represents terribly uncomfortable.

次要结局

未报告次要终点

研究者

发起方
Chiayi Christian Hospital
申办方类型
Other
责任方
Sponsor

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