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

NCT05204056 | Completed DMC

• 1 other identifier: 2018-149
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Blood Loss, Postoperative

Outcome Measures

Primary Outcomes (1)

• Reduced pain

  the pain after operation reduced significantly.

  three days after operation

Secondary Outcomes (1)

• Reduced bleeding

  24 hours drainage.

Other Outcomes (1)

• increased HSS scores

  3 days after operation

Study Arms (3)

Group A

EXPERIMENTAL

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

Drug: iced normal saline; Drug: Tranexamic acid injection

Group B

EXPERIMENTAL

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

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

Control group

ACTIVE COMPARATOR

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

Drug: Tranexamic acid injection

Interventions

iced normal saline DRUG

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

Also known as: H19983149

Group A; Group B

Tranexamic acid injection DRUG

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

Also known as: H43020565

Control group; Group A; Group B

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.

Group B

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subsequent arthritis (including rheumatoid arthritis, Gouty arthritis, traumatic arthritis, etc.) were excluded.

Sponsors & Collaborators

• Yantai Yuhuangding Hospital: lead

Study Sites (1)

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Hemorrhage

Interventions

Tranexamic Acid; Morphine; Epinephrine; Perfusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hemorrhage

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Investigative Techniques

Study Officials

• Laijian Sui, Doctor

  Yantai Yuhuangding Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: March 2, 2018
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: January 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)