Multimodal Analgesia in TKA. The Role of Tapentadol
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Post-operative pain
研究概览
简要总结
Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR).
详细描述
As the population ages and becomes more active, the demand for TKR surgery is expected to increase. However, the treatment of TKR pain remains a challenge.
Postoperative pain is associated with longer hospital stays, lower satisfaction, increased opioid consumption, and transition to chronic pain. In TKR, the risk of chronic pain can be as high as 20%.
A suggested method of anesthesia and pain relief is the use of spinal anesthesia along with multimodal analgesia that includes an adductor canal block.
In our hospital, the multimodal analgesia protocol consists of intraoperative sedation with dexmedetomidine, a low dose of ketamine, paracetamol, NSAIDs, and magnesium. Dexamethasone and droperidol are preferred as antiemetics as they can improve the analgesic outcome.
To minimize the use of opioids, the administration of tramadol used to be the standard of care. Tapentadol is an opioid that can be equally effective in the treatment of postoperative pain and reduces the incidence of chronic pain after TKR.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients for elective TKR
- •ASA PS I - III
排除标准
- •Patient refusal
- •Cognitive disfunction
- •Severe psychiatric disease
- •Under medication with MAO inhibitors, tricyclic antidepressants, serotonin reuptake inhibitors
- •Not speaking Greek
- •Known allergy to the study drugs
- •Contraindications for any of the study drugs
- •Chronic renal failure (GFR < 50 ml/h)
- •Liver failure
- •Known regular use or misuse of opioids
- •Pregnant women
- •Patients undergoing general anesthesia
研究组 & 干预措施
Tramadol
Tramadol will be administered in a multimodal analgesic approach to manage postoperative pain.
干预措施: Tramadol (Drug)
Tapentadol
Tapentadol will be administered in a multimodal analgesic approach to manage postoperative pain.
干预措施: Tapentadol (Drug)
结局指标
主要结局
Post-operative pain
时间窗: 3rd postoperative day
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
次要结局
- Outcome(6 weeks after surgery)
- Pain severity(6 weeks after surgery)
- Post-operative pain(6 months after surgery)
- Patient Satisfaction(5 days after surgery at Discharge)
- Depression(5 days after surgery at Discharge)
- Function(6 weeks after surgery)
- Neuropathic pain(6 months after surgery)
- Arthritis impact(6 weeks after surgery)
- Health Status(6 weeks after surgery)
- Quality of life postoperatively(6 months after surgery)
研究者
Elena Arnaoutoglou
Professor in Anesthesiology
University of Thessaly