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

Primary Purpose

Pain, Postoperative, Blood Loss, Postoperative

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
iced normal saline
Tranexamic acid injection
Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion
Sponsored by
Yantai Yuhuangding Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Yantai Yuhuangding Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group A

Group B

Control group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Reduced pain
the pain after operation reduced significantly.

Secondary Outcome Measures

Reduced bleeding
The blood loss reduced significantly after operation.

Full Information

First Posted
January 10, 2022
Last Updated
January 10, 2022
Sponsor
Yantai Yuhuangding Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05204056
Brief Title
Application of Iced Normal Saline Combined With Cocktail Perfusion in Total Knee Arthroplasty
Official Title
Application of Iced Normal Saline Combined With Cocktail Perfusion in Total Knee Arthroplasty: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 2, 2018 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yantai Yuhuangding Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Blood Loss, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group
Intervention Type
Drug
Intervention Name(s)
iced normal saline
Other Intervention Name(s)
H19983149
Intervention Description
Iced normal saline (20ml) was given intraoperative joint cavity infusion therapy
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Other Intervention Name(s)
H43020565
Intervention Description
20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.
Intervention Type
Other
Intervention Name(s)
Cocktail (composing by Ropivacaine, Morphine and Epinephrine) perfusion
Intervention Description
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 Outcome Measure Information:
Title
Reduced pain
Description
the pain after operation reduced significantly.
Time Frame
three days after operation
Secondary Outcome Measure Information:
Title
Reduced bleeding
Description
The blood loss reduced significantly after operation.
Time Frame
24 hours drainage.
Other Pre-specified Outcome Measures:
Title
increased HSS scores
Description
The HSS scores increased markedly after operation.
Time Frame
3 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laijian Sui, Doctor
Organizational Affiliation
Yantai Yuhuangding Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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