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

January 10, 2022 updated by: Yantai Yuhuangding Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Yantai, Shandong, China, 264000
        • Yantai Yuhuangding Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline.
Drug: iced normal saline
Iced normal saline (20ml) was given intraoperative joint cavity infusion therapy
Other Names:
  • H19983149
Drug: Tranexamic acid injection
20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.
Other Names:
  • H43020565
Experimental: Group B
Twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic
Drug: iced normal saline
Iced normal saline (20ml) was given intraoperative joint cavity infusion therapy
Other Names:
  • H19983149
Drug: Tranexamic acid injection
20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.
Other Names:
  • H43020565
Other: 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.
Active Comparator: Control group
Twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group
Drug: Tranexamic acid injection
20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.
Other Names:
  • H43020565

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
increased HSS scores
Time Frame: 3 days after operation
The HSS scores increased markedly after operation.
3 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yantai Yuhuangding Hospital

Investigators

  • Study Chair: Laijian Sui, Doctor, Yantai Yuhuangding Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2018

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 10, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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