Application of Iced Normal Saline Combined With Cocktail Perfusion in Total Knee Arthroplasty: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduced pain
研究概览
简要总结
Sixty patients undergoing TKA were divided into three groups, then three different intro-operative articular cavity perfusion treatment was given according to the randomized, double-blind and controlled rule. One way ANOVA analysis on visual analogue scale (VAS) score, functional recovery, drainage, and edema of the affected limb were performed to assess the efficiency of the treatment in the following three days after the operation.
详细描述
Patients with confirmed primary knee osteoarthritis in stage IV by preoperative X-ray were included in present study, whilst subsequent arthritis (including rheumatoid arthritis, Gouty arthritis, traumatic arthritis, etc.) were excluded. After assessment, sixty qualified patients who voluntarily participating in this study have understood the research project were included in the present study and the corresponding consent forms were signed. Patients were randomly classified into three groups with different interventions, each group contains 20 patients. Group A: twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline; Group B twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic; the left twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group. All the study personnel including the patients, their family members, the nursing staff and the leading operator were blind to the treatment allocation.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed primary knee osteoarthritis in stage IV by preoperative X-ray were included in present study. Kellgren-Lawrence Radiology standards for stage IV were listed as follows: obviously narrowed joint space; vast osteophytes are formed; severe osteosclerosis under the cartilage; bone hypertrophy and evident deformity
排除标准
- •Subsequent arthritis (including rheumatoid arthritis, Gouty arthritis, traumatic arthritis, etc.) were excluded.
研究组 & 干预措施
Group A
Twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline.
干预措施: iced normal saline (Drug)
Group A
Twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline.
干预措施: Tranexamic acid injection (Drug)
Group B
Twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic
干预措施: iced normal saline (Drug)
Group B
Twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic
干预措施: Tranexamic acid injection (Drug)
Group B
Twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic
干预措施: Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion (Other)
Control group
Twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group
干预措施: Tranexamic acid injection (Drug)
结局指标
主要结局
Reduced pain
时间窗: three days after operation
the pain after operation reduced significantly.
次要结局
- Reduced bleeding(24 hours drainage.)