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

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-25

Study Completion Date

2024-05-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

without triamcinolone

Intervention Type 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.

Low dose triamcinolone

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

Group Type EXPERIMENTAL

20mg triamcinolone

Intervention Type 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.

Moderate dose triamcinolone

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

Group Type EXPERIMENTAL

40mg triamcinolone

Intervention Type 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.

High dose triamcinolone

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

Group Type EXPERIMENTAL

80mg triamcinolone

Intervention Type 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.

Interventions

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without triamcinolone

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

Intervention Type DRUG

20mg triamcinolone

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.

Intervention Type DRUG

40mg triamcinolone

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.

Intervention Type DRUG

80mg triamcinolone

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.

Intervention Type DRUG

Other Intervention Names

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Placebo Low dose triamcinolone Moderate dose triamcinolone High dose triamcinolone

Eligibility Criteria

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Inclusion Criteria

1. age in the range of 50 to 85 years old
2. patients with knee osteoarthritis requiring primary unilateral total knee replacement
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 Criteria

1. Non-osteoarthritis (rheumatoid arthritis, traumatic arthritis, septicemic arthritis, etc.)
2. History of knee surgery or knee injury, such as high tibial osteotomy, meniscus repair, 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

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No