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

NCT ID: NCT06243575

Last Updated: 2024-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Multimodal Intraosseous Femoral Injection

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

Group Type EXPERIMENTAL

Multimodal Intraosseous Femoral Injection

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Multimodal Intraosseous Tibial Injection

Intervention Type DRUG

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

Interventions

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Multimodal Intraosseous Femoral Injection

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

Intervention Type DRUG

Multimodal Intraosseous Tibial Injection

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thakrit Chompoosang, MD

Role: STUDY_DIRECTOR

Department of Medical Services Ministry of Public Health of Thailand

Locations

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Rajavithi hospital

Phaya Thai, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Thakrit Chompoosang, MD

Role: CONTACT

+66846461916

Tanahem Wijit, MD

Role: CONTACT

+66956855458

References

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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.

Reference Type BACKGROUND
PMID: 35272897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25922311 (View on PubMed)

Other Identifiers

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149/66

Identifier Type: -

Identifier Source: org_study_id

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