Osteoarthritis, KneePhase 4LIA;TKANCT05997238
Evaluation of the Effect of Triamcinolone at Different Doses on LIA During TKA
A Phase 4 study testing without triamcinolone, 20mg triamcinolone and 40mg triamcinolone in people with Osteoarthritis, Knee, run by Peking University Third Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of different doses of triamcinolone for local infiltration analgesia during total knee replacement Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- without triamcinolone, 20mg triamcinolone and 40mg triamcinolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2023to 1 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100181
About this study
Official title: Evaluation of the Effect of Triamcinolone at Different Doses on Local Infiltration Anesthesia During Total Knee Arthroplasty
To evaluate the efficacy and safety of different doses of triamcinolone for local infiltration analgesia during total knee replacement
Read the detailed 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- without triamcinolone, 20mg triamcinolone, 40mg triamcinolone, 80mg triamcinolone
- Keywords
- total knee arthroplasty, triamcinolone, local infiltration anesthesia
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
without triamcinoloneDrug
Also called Placebo
The preparation contains only the basic formula. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml.
20mg triamcinoloneDrug
Also called Low dose 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.
40mg triamcinoloneDrug
Also called Moderate dose 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.
80mg triamcinoloneDrug
Also called High dose 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: 80mg triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain visual analogue scale score
pain visual analogue scale score; range from 0 to 10; The lower it is, the better the analgesic effect
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks after surgery
Secondary outcomes (9)
Blood routine
Assay index including white blood cell count and neutrophil count.
Measured: Postoperative day 1
Blood routine
Assay index including white blood cell count and neutrophil count.
Measured: Postoperative day 2
Blood routine
Assay index including white blood cell count and neutrophil count.
Measured: Postoperative day 3
Test index of drainage liquefaction
Assay index
Measured: Postoperative day 1
Complication rate
Follow-up visit
Measured: Three months after surgery
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index; range from 0 to 100; A higher score indicates better knee function
Measured: Three months after surgery
Knee range of motion
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Measured: Postoperative day 1
Knee range of motion
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Measured: Postoperative day 2
Knee range of motion
The rehabilitation doctor takes the measurements of changes in knee joint motion during the first three days after surgery
Measured: Postoperative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start25 Apr 2023
- Primary completion12 Feb 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tian Hua, doctor, Study chair, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997238
- Sponsor's protocol ID
- Triamcinolone68480
- Acronym
- LIA;TKA
- Status last verified
- Apr 2023
- First submitted
- 17 May 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Triamcinolone at Different Doses on Local Infiltration Anesthesia During Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05997238
- Acronym / sponsor ID
- LIA;TKA / Triamcinolone68480
- Conditions
- Osteoarthritis, Knee
- Keywords
- total knee arthroplasty, triamcinolone, local infiltration anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of different doses of triamcinolone for local infiltration analgesia during total knee replacement
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: without triamcinoloneLIA preparation was administered without triamcinolone. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml. |
| Low dose triamcinolone | Experimental | Drug: 20mg triamcinoloneAdd 20mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml. |
| Moderate dose triamcinolone | Experimental | Drug: 40mg triamcinoloneadd 40mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml. |
| High dose triamcinolone | Experimental | Drug: 80mg triamcinoloneadd 80mg triamcinolone to the LIA preparation. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| without triamcinoloneAlso: PlaceboThe preparation contains only the basic formula. The base formula contains 150mg ropivacaine and 0.5mg epinephrine. Add normal saline and mix to 80ml. | Drug | Placebo |
| 20mg triamcinoloneAlso: Low dose triamcinolone20mg 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. | Drug | Low dose triamcinolone |
| 40mg triamcinoloneAlso: Moderate dose triamcinolone40mg 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. | Drug | Moderate dose triamcinolone |
| 80mg triamcinoloneAlso: High dose triamcinolone80mg 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. | Drug | High dose triamcinolone |
Primary outcome
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
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
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
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
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
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
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
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
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
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
9 secondary outcomes
Blood routine
Time frame: Postoperative day 1
Blood routine
Time frame: Postoperative day 2
Blood routine
Time frame: Postoperative day 3
Test index of drainage liquefaction
Time frame: Postoperative day 1
Complication rate
Time frame: Three months after surgery
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Time frame: Three months after surgery
Knee range of motion
Time frame: Postoperative day 1
Knee range of motion
Time frame: Postoperative day 2
Knee range of motion
Time frame: Postoperative day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tian Hua, doctor study chair
Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing without triamcinolone, 20mg triamcinolone and 40mg triamcinolone in people with Osteoarthritis, Knee, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain visual analogue scale score (time frame: 2 hours after surgery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.