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

NCT06243575 | Unknown DMC

• 1 other identifier: 149/66
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

total knee arthroplasty; intraosseous infiltration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• knee range of motion

  post operative 2 weeks

• Side effects and complications

  intraoperative to post operative 2weeks

Study Arms (2)

Multimodal Intraosseous Femoral Injection

EXPERIMENTAL

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

Drug: Multimodal Intraosseous Femoral Injection

Multimodal Intraosseous Tibial Injection

EXPERIMENTAL

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

Drug: Multimodal Intraosseous Tibial Injection

Interventions

Multimodal Intraosseous Femoral Injection DRUG

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

Multimodal Intraosseous Femoral Injection

Multimodal Intraosseous Tibial Injection DRUG

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

Multimodal Intraosseous Tibial Injection

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi hospital

Phaya Thai, Bangkok, 10400, Thailand

RECRUITING

Related 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.

  PMID: 35272897 BACKGROUND

• 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.

  PMID: 25922311 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Thakrit Chompoosang, MD

  Department of Medical Services Ministry of Public Health of Thailand

  STUDY DIRECTOR

Central Study Contacts

Thakrit Chompoosang, MD

CONTACT

+66846461916; tk_ortho@hotmail.com

Tanahem Wijit, MD

CONTACT

+66956855458; troy.erdos@gmail.com

Study Design

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

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 6, 2024
• Study Start: February 1, 2024
• Primary Completion: March 30, 2024
• Study Completion: December 31, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)