Clinical trial NCT06243575: Comparison of Outcomes Between Intraosseous Femoral and Tibial Injection in Simultaneous Bilateral Total Knee Arthroplasty Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Keywords: total knee arthroplasty
intraosseous infiltration
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2024-02-06
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pain score (Visual analog scale)
timeFrame: at 12 hours, 24 hours, 48 hours and 2 weeks after surgery
Secondary outcomes:
measure: Amount of painkillers used
timeFrame: up to 24 hours after surgery
measure: Post operative blood loss
timeFrame: intraoperative and up to 48 hours postoperatively (include intraoperative and drain)
measure: Knee and Osteoarthritis Outcome Score (KOOS)
timeFrame: post operative 2 weeks
measure: knee range of motion
timeFrame: post operative 2 weeks
measure: Side effects and complications
timeFrame: intraoperative to post operative 2weeks
measure: Length of hospital stay
timeFrame: Admit to discharge date (up to 7 days)
Other outcomes:
Locations:
city: Phaya Thai
country: Thailand
facility: Rajavithi hospital
state: Bangkok
Study officials:
affiliation: Department of Medical Services Ministry of Public Health of Thailand
name: Thakrit Chompoosang, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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.