Comparison of Outcomes Between Intraosseous Femoral and Tibial Injection in Simultaneous Bilateral Total Knee Arthroplasty Patients

Pain, Postoperative Clinical Trial

Official title:

Comparison of Outcomes Between Multimodal Intraosseous Femoral Injection and Multimodal Intraosseous Tibial Injection, A Randomized Controlled Trial in Simultaneous Bilateral Total Knee Arthroplasty Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243575
• Other study ID #: 149/66
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: Rajavithi Hospital
• Contact: Thakrit Chompoosang, MD
• Phone: +66846461916
• Email: tk_ortho[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In patients with osteoarthritis of the knee whose pain cannot be relieved by conservative treatment, total knee arthroplasty (TKA) is the operation that increases the quality of life for the patient. Pain management after total knee arthroplasty TKA is an important consideration to improve patient outcomes and reduce length of stay. Periarticular injections of the knee are one of the techniques used to reduce pain after surgery. Studies have shown that compared to other methods of pain relief, they are effective and safe. At present, no studies to compare between multimodal intraosseous femoral injection & multimodal intraosseous tibial injection in Simultaneous Bilateral TKA patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Patients who will undergo bilateral Total knee Replacement due to osteoarthritis of both knees

• Used of a cemented, PS design TKA surgery.

• Able to give informed consent

Exclusion Criteria:

• Revision TKA

• History of previous knee or hip surgery

• History of allergic reaction or side effects to the drug that will be used in the experiment

• Underlying diseases of chronic kidney disease or chronic liver disease (Child Pugh B or C)

• Pregnancy

• History of coagulopathy or abnormal blood coagulation profile(INR >1.4 or aPTT ratio > 1.4)

• History of platelet dysfunction or platelet count < 140,0000/mm3

• History of Thromboembolism

• Use of Anticoagulants.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Multimodal Intraosseous Femoral Injection
Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in femoral canal
• Multimodal Intraosseous Tibial Injection
Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in tibial canal

Locations

Country	Name	City	State
Thailand	Rajavithi hospital	Phaya Thai	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

Brozovich AA, Incavo SJ, Lambert BS, Sullivan TC, Wininger AE, Clyburn TA, Taraballi F, Park KJ. Intraosseous Morphine Decreases Postoperative Pain and Pain Medication Use in Total Knee Arthroplasty: A Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2022 Jun;37(6S):S139-S146. doi: 10.1016/j.arth.2021.10.009. Epub 2022 Mar 7. — View Citation

Fan L, Zhu C, Zan P, Yu X, Liu J, Sun Q, Li G. The Comparison of Local Infiltration Analgesia with Peripheral Nerve Block following Total Knee Arthroplasty (TKA): A Systematic Review with Meta-Analysis. J Arthroplasty. 2015 Sep;30(9):1664-71. doi: 10.1016/j.arth.2015.04.006. Epub 2015 Apr 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score (Visual analog scale)	Visual analog scale (VAS) score from 0-10(0 was no pain, 10 was worst pain ) between multimodal intraosseous femoral injection & multimodal intraosseous tibial injection	at 12 hours, 24 hours, 48 hours and 2 weeks after surgery
Secondary	Amount of painkillers used		up to 24 hours after surgery
Secondary	Post operative blood loss		intraoperative and up to 48 hours postoperatively (include intraoperative and drain)
Secondary	Knee and Osteoarthritis Outcome Score (KOOS)	minimum and maximum values(0-100), higher scores mean a better outcome.	post operative 2 weeks
Secondary	knee range of motion		post operative 2 weeks
Secondary	Side effects and complications		intraoperative to post operative 2weeks
Secondary	Length of hospital stay	Length of hospital stay record in number of days	Admit to discharge date (up to 7 days)