Evaluation of the Effect of Triamcinolone at Different Doses on LIA During TKA

Last updated: June 11, 2024
Sponsor: Peking University Third Hospital
Overall Status: Completed

Phase

4

Condition

N/A

Treatment

80mg triamcinolone

40mg triamcinolone

20mg triamcinolone

Clinical Study ID

NCT05997238
Triamcinolone68480
  • Ages 50-85
  • All Genders

Study Summary

To evaluate the efficacy and safety of different doses of triamcinolone for local infiltration analgesia during total knee replacement

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. age in the range of 50 to 85 years old

  2. patients with knee osteoarthritis requiring primary unilateral total kneereplacement

  3. the body mass index in the range of 18 to 36 kg/m2

  4. possess the physical status I-III of American Society of Anesthesiologists

  5. the patient and his family members agree and sign the informed consent

Exclusion

Exclusion Criteria:

  1. Non-osteoarthritis (rheumatoid arthritis, traumatic arthritis, septicemic arthritis,etc.)

  2. History of knee surgery or knee injury, such as high tibial osteotomy, meniscusrepair, ligament reconstruction, etc

  3. Flexion deformity ≥30°, internal and external varus deformity ≥15°

  4. People allergic to the drugs used in this study

  5. Patients who had used glucocorticoids within 3 months before surgery

Study Design

Total Participants: 120
Treatment Group(s): 4
Primary Treatment: 80mg triamcinolone
Phase: 4
Study Start date:
April 25, 2023
Estimated Completion Date:
May 01, 2024

Study Description

Participants were enrolled according to protocol requirements. Patients who meet all inclusion criteria and do not have any exclusion criteria will be considered for inclusion in the study and will provide the relevant information used orally and in writing. Patients were divided into four groups according to the dose of triamcinolone in the peripheral infiltrating anesthetic preparation. All of which are appropriate for their surgical treatment, and the purpose of the study is to determine which formula is clinically better. All patients enrolled in this study were voluntary participants and signed informed consent. On the day of the surgery, the anesthesiologist prepares a mixture of medications based on patient groups, which are then handed to the operating room nurse. The timing, dose, and site of injection were consistent. Before the prosthesis is installed, the mixture is injected into the upper part of the patella, the posterior joint capsule, and the patellar tendon. After the prosthesis was installed, the mixture was injected into the lateral joint capsule and subcutaneous tissue. The patient, the rehabilitation physician, and the ward nurse did not know the type of mixed drug preparation injected by the patient.

Connect with a study center

  • Peking University Third Hospital

    Beijing, Beijing 100181
    China

    Site Not Available

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