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Clinical Trials/NCT06243575
NCT06243575
Recruiting
Not Applicable

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

Rajavithi Hospital1 site in 1 country20 target enrollmentFebruary 1, 2024

Overview

Phase
Not Applicable
Intervention
Multimodal Intraosseous Femoral Injection
Conditions
Pain, Postoperative
Sponsor
Rajavithi Hospital
Enrollment
20
Locations
1
Primary Endpoint
Pain score (Visual analog scale)
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
December 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Multimodal Intraosseous Femoral Injection

Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in femoral canal

Intervention: Multimodal Intraosseous Femoral Injection

Multimodal Intraosseous Tibial Injection

Intraosseous injection of Ketorolac 15mg and Tranexamic acid 500mg in tibial canal

Intervention: Multimodal Intraosseous Tibial Injection

Outcomes

Primary Outcomes

Pain score (Visual analog scale)

Time Frame: at 12 hours, 24 hours, 48 hours and 2 weeks after surgery

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

Secondary Outcomes

  • Amount of painkillers used(up to 24 hours after surgery)
  • Post operative blood loss(intraoperative and up to 48 hours postoperatively (include intraoperative and drain))
  • Knee and Osteoarthritis Outcome Score (KOOS)(post operative 2 weeks)
  • Length of hospital stay(Admit to discharge date (up to 7 days))
  • knee range of motion(post operative 2 weeks)
  • Side effects and complications(intraoperative to post operative 2weeks)

Study Sites (1)

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