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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05204056
• Other study ID #: 2018-149
• Status: Completed
• Phase: N/A
• Start date: March 2, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: January 2022
• Source: Yantai Yuhuangding Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Postoperative
• Pain, Postoperative
• Postoperative Hemorrhage

Intervention

Drug:
• iced normal saline
Iced normal saline (20ml) was given intraoperative joint cavity infusion therapy
• Tranexamic acid injection
20ml of tranexamic was given with iced normal saline for intraoperative joint cavity infusion.

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.

Locations

Country	Name	City	State
China	Yantai Yuhuangding Hospital	Yantai	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yantai Yuhuangding Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	increased HSS scores	The HSS scores increased markedly after operation.	3 days after operation
Primary	Reduced pain	the pain after operation reduced significantly.	three days after operation
Secondary	Reduced bleeding	The blood loss reduced significantly after operation.	24 hours drainage.