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OpenTrials
Completed

NCT Number: NCT05204056

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

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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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iced normal saline

Drug

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

Other names: H19983149

Tranexamic acid injection

Drug

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

Other names: H43020565

Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion

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.

Primary outcomes

  1. Reduced pain

    Time frame: three days after operation

    the pain after operation reduced significantly.

Secondary outcomes

  1. Reduced bleeding

    Time frame: 24 hours drainage.

    The blood loss reduced significantly after operation.

Other outcomes

  1. increased HSS scores

    Time frame: 3 days after operation

    The HSS scores increased markedly after operation.

Sponsors and collaborators

Lead sponsor

Yantai Yuhuangding Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2022
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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