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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-02

Study Completion Date

2018-08-01

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.

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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.

Conditions

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Pain, Postoperative Blood Loss, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A

Twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline.

Group Type EXPERIMENTAL

iced normal saline

Intervention Type DRUG

Iced normal saline (20ml) was given intraoperative joint cavity infusion therapy

Tranexamic acid injection

Intervention Type DRUG

20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.

Group B

Twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic

Group Type EXPERIMENTAL

iced normal saline

Intervention Type DRUG

Iced normal saline (20ml) was given intraoperative joint cavity infusion therapy

Tranexamic acid injection

Intervention Type DRUG

20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.

Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion

Intervention Type OTHER

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.

Control group

Twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group

Group Type ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type DRUG

20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.

Interventions

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iced normal saline

Iced normal saline (20ml) was given intraoperative joint cavity infusion therapy

Intervention Type DRUG

Tranexamic acid injection

20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.

Intervention Type DRUG

Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion

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.

Intervention Type OTHER

Other Intervention Names

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H19983149 H43020565

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