Study on the Clinical Effectiveness of Oral Strong Opioids for Common Orthopedic Surgeries Following Multimodal Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in pain scores from baseline
研究概览
简要总结
This is a prospective observational case study, focusing on the clinical effectiveness of oral strong opioids for pain management following common orthopedic surgeries.The study aims to evaluate the effectiveness of multimodal analgesia with oral strong opioids, reduce common opioid-related side effects, and improve patient compliance and satisfaction.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or older
- •Must undergo one of the following treatments:
- •(1) Fracture of upper or lower limbs or pelvis requiring internal fixation surgery (2) Spinal fusion surgery (3) Joint replacement surgery
- •Requiring multimodal analgesics for postoperative pain control, with oral strong opioids as the primary opioid analgesic, as assessed by his/her physician.
- •Voluntarily sign the informed consent form and agree to the collection of clinical questionnaires and medical-related information for this study.
排除标准
- •Patients who have not received any or have only received oral potent opioids for no more than 1 day during the postoperative hospitalization period (including those known to be intolerant or allergic to opioid medications).
- •Patients who have received or are expected to use long-acting opioid injections within 7 days before surgery or during the postoperative hospitalization period.
- •Patients who use patient-controlled analgesics for pain control after surgery.
- •Patients with a history of substance abuse or who require continuous treatment with other opioid receptor agonists or antagonists (such as naloxone or methadone).
- •Patients with a history of mental illness who continue to require medication control from 28 days before surgery and until discharge.
- •Other cases deemed ineligible by the study investigator.
研究组 & 干预措施
Fracture fixation
Fracture of upper or lower limbs or pelvis requiring internal fixation surgery
干预措施: Multimodal analgesia with oral strong opioids (Drug)
Spinal fusion
Spinal fusion surgery
干预措施: Multimodal analgesia with oral strong opioids (Drug)
Arthroplasty
Joint replacement surgery
干预措施: Multimodal analgesia with oral strong opioids (Drug)
结局指标
主要结局
Change in pain scores from baseline
时间窗: Twice daily during hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery
Assess the efficacy of including oral strong opioids in multimodal pain control. For this objective, we will observe changes in pain scores among participants during postoperative treatment.
次要结局
- Occurence of adverse events(During hospitalization (approximately within 1 week))
- Compliance of oral strong opioids(During hospitalization (approximately within 1 week))
- Physician's global impression - improvement scale(CGI-I)(During hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery)
- Satisfation of the pain control as per patients' report outcome(End of hospitalization (approximately 1 week after surgery))
研究者
Tsu-Te Yeh
Attending Surgeon
Tri-Service General Hospital