Application of Iced Normal Saline Combined With Cocktail Perfusion in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Application of Iced Normal Saline Combined With Cocktail Perfusion in Total Knee Arthroplasty: Randomized Controlled Trial

Conditions
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Pain, Postoperative, Blood Loss, Postoperative

Intervention / Treatment
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* Drug: iced normal saline
* Drug: Tranexamic acid injection
* Other: Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Subsequent arthritis (including rheumatoid arthritis, Gouty arthritis, traumatic arthritis, etc.) were excluded.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Recruited patients were divided into three groups with different recipes. 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. Intravertebral anaesthesia was selected for the surgery and the operations were performed by the same surgical team. The average operation time was about 1.5 hours, which lasted from the compression of the tourniquet to completed wound dressing.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline. | Drug: iced normal saline<br>* Iced normal saline (20ml) was given intraoperative joint cavity infusion therapy<br>* Other names: H19983149;Drug: Tranexamic acid injection<br>* 20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.<br>* Other names: H43020565;|
| Experimental: Group B<br>Twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic | Drug: iced normal saline<br>* Iced normal saline (20ml) was given intraoperative joint cavity infusion therapy<br>* Other names: H19983149;Drug: Tranexamic acid injection<br>* 20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.<br>* Other names: H43020565;Other: Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion<br>* Cocktail was formulated during the operation by mixing Ropivacaine 150mg, Morphine 10mg and Epinephrine 1mg, then normal saline was used to dilute the mixture to 60ml. Then the cocktail mixture was applied for the joint cavity perfusion.<br>|
| Active Comparator: Control group<br>Twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group | Drug: Tranexamic acid injection<br>* 20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.<br>* Other names: H43020565;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced pain | the pain after operation reduced significantly. | three days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced bleeding | The blood loss reduced significantly after operation. | 24 hours drainage. |