Skip to main content
OpenTrials
Completed

NCT Number: NCT05997238

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100181, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age in the range of 50 to 85 years old
  • patients with knee osteoarthritis requiring primary unilateral total knee replacement
  • the body mass index in the range of 18 to 36 kg/m2
  • possess the physical status I-III of American Society of Anesthesiologists
  • the patient and his family members agree and sign the informed consent

Exclusion criteria

  • Non-osteoarthritis (rheumatoid arthritis, traumatic arthritis, septicemic arthritis, etc.)
  • History of knee surgery or knee injury, such as high tibial osteotomy, meniscus repair, ligament reconstruction, etc
  • Flexion deformity ≥30°, internal and external varus deformity ≥15°
  • People allergic to the drugs used in this study
  • Patients who had used glucocorticoids within 3 months before surgery

Treatment and study plan

without triamcinolone

Drug

The preparation contains only the basic formula. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.

Other names: Placebo

20mg triamcinolone

Drug

20mg triamcinolone was added to the preparation. Mix 20mg triamcinolone and the basic formula to make a mixed preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.

Other names: Low dose triamcinolone

40mg triamcinolone

Drug

40mg triamcinolone was added to the preparation. Mix 40mg triamcinolone and the basic formula to make a mixed preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.

Other names: Moderate dose triamcinolone

80mg triamcinolone

Drug

80mg triamcinolone was added to the preparation. Mix 80mg triamcinolone and the basic formula to make a mixed preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.

Other names: High dose triamcinolone

Primary outcomes

  1. pain visual analogue scale score

    Time frame: 2 hours after surgery

    pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect

  2. pain visual analogue scale score

    Time frame: 4 hours after surgery

    pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect

  3. pain visual analogue scale score

    Time frame: 8 hours after surgery

    pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect

  4. pain visual analogue scale score

    Time frame: 24 hours after surgery

    pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect

  5. pain visual analogue scale score

    Time frame: 48 hours after surgery

    pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect

  6. pain visual analogue scale score

    Time frame: 72 hours after surgery

    pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect

  7. pain visual analogue scale score

    Time frame: 2 weeks after surgery

    pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect

  8. pain visual analogue scale score

    Time frame: 4 weeks after surgery

    pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect

  9. pain visual analogue scale score

    Time frame: 8 weeks after surgery

    pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect

  10. pain visual analogue scale score

    Time frame: 12 weeks after surgery

    pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect

Secondary outcomes

  1. Blood routine

    Time frame: Postoperative day 1

    Assay index including white blood cell count and neutrophil count.

  2. Blood routine

    Time frame: Postoperative day 2

    Assay index including white blood cell count and neutrophil count.

  3. Blood routine

    Time frame: Postoperative day 3

    Assay index including white blood cell count and neutrophil count.

  4. Test index of drainage liquefaction

    Time frame: Postoperative day 1

    Assay index

  5. Complication rate

    Time frame: Three months after surgery

    Follow-up visit

  6. The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index

    Time frame: Three months after surgery

    The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; range from 0 to 100; A higher score indicates better knee function

  7. Knee range of motion

    Time frame: Postoperative day 1

    The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery

  8. Knee range of motion

    Time frame: Postoperative day 2

    The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery

  9. Knee range of motion

    Time frame: Postoperative day 3

    The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Evaluation of the Effect of Triamcinolone at Different Doses on Local Infiltration Anesthesia During Total Knee Arthroplasty

Acronym: LIA;TKA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2023
Registry last updated
Jun 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.