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

NCT05997238 | Completed Phase 4 DMC

• 1 other identifier: Triamcinolone68480
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis, Knee

Keywords

total knee arthroplasty; triamcinolone; local infiltration anesthesia

Outcome Measures

Primary Outcomes (10)

• pain visual analogue scale score

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

  2 hours after surgery

• pain visual analogue scale score

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

  4 hours after surgery

• pain visual analogue scale score

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

  8 hours after surgery

• pain visual analogue scale score

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

  24 hours after surgery

• pain visual analogue scale score

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

  48 hours after surgery

• pain visual analogue scale score

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

  72 hours after surgery

• pain visual analogue scale score

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

  2 weeks after surgery

• pain visual analogue scale score

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

  4 weeks after surgery

• pain visual analogue scale score

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

  8 weeks after surgery

• pain visual analogue scale score

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

  12 weeks after surgery

Secondary Outcomes (9)

• Blood routine

  Postoperative day 1

• Blood routine

  Postoperative day 2

• Blood routine

  Postoperative day 3

• Test index of drainage liquefaction

  Postoperative day 1

• Complication rate

  Three months after surgery

Study Arms (4)

Placebo

PLACEBO COMPARATOR

LIA preparation was administered without triamcinolone. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.

Drug: without triamcinolone

Low dose triamcinolone

EXPERIMENTAL

Add 20mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.

Drug: 20mg triamcinolone

Moderate dose triamcinolone

EXPERIMENTAL

add 40mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.

Drug: 40mg triamcinolone

High dose triamcinolone

EXPERIMENTAL

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

Drug: 80mg triamcinolone

Interventions

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.

Also known as: Placebo

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.

Also known as: Low dose triamcinolone

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.

Also known as: Moderate dose triamcinolone

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.

Also known as: High dose triamcinolone

High dose triamcinolone

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100181, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Tian Hua, doctor

  Director

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent researcher, who would not meet or interact with patients before recruiting them, compiled a computer-generated randomised list using 1:1 assignments and random blocks of 8, 6 or 4 to ensure the invisibility of assignments. The groups corresponding to the numbers generated by the random number generator were placed in opaque envelopes and sealed, and the enrolled patients were assigned envelopes in the chronological order in which they were enrolled. On the day of surgery, the anesthesiologist prepares to mix the drug preparation after opening the sealed envelope, which is then handed to the operating room nurse. The patient, the rehabilitation physician, and the ward nurse did not know the type of drug mixture the patient was injected with.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An independent researcher, who would not meet or interact with patients before recruiting them, compiled a computer-generated randomised list using a 1:1:1:1 assignment and random blocks of 12, 8 or 4 to ensure the concealability of the assignment. The groups corresponding to the numbers generated by the random number generator were placed in opaque envelopes and sealed, and the enrolled patients were assigned envelopes in the chronological order in which they were enrolled.

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: August 18, 2023
• Study Start: April 25, 2023
• Primary Completion: February 12, 2024
• Study Completion: May 1, 2024
• Last Updated: June 13, 2024

Record last verified: 2023-04

Locations

CN (1)