Application of Iced Normal Saline Combined With Cocktail Perfusion in Total Knee Arthroplasty
- Conditions
- Blood Loss, PostoperativePain, Postoperative
- Interventions
- Drug: iced normal salineOther: Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion
- Registration Number
- NCT05204056
- Lead Sponsor
- Yantai Yuhuangding Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Subsequent arthritis (including rheumatoid arthritis, Gouty arthritis, traumatic arthritis, etc.) were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Tranexamic acid injection Twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group Group B Tranexamic acid injection Twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic Group A Tranexamic acid injection Twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline. Group A iced normal saline Twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline. Group B Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion Twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic Group B iced normal saline Twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic
- Primary Outcome Measures
Name Time Method Reduced pain three days after operation the pain after operation reduced significantly.
- Secondary Outcome Measures
Name Time Method Reduced bleeding 24 hours drainage. The blood loss reduced significantly after operation.
Trial Locations
- Locations (1)
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China