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

Yantai Yuhuangding Hospital

Status: Completed

Conditions: Blood Loss, Postoperative; Pain, Postoperative

Treatments: Drug: Tranexamic acid injection; Drug: iced normal saline; Other: Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05204056

2018-149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Group A

Experimental group

Description:

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

Treatment:

Drug: iced normal saline

Drug: Tranexamic acid injection

Group B

Experimental group

Description:

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

Treatment:

Other: Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion

Drug: iced normal saline

Drug: Tranexamic acid injection

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Tranexamic acid injection