Adrenal Cortex HormonesNCT07337772
Comparing Different Doses of Corticosteroids in Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty
A study testing LIA with different doses of Diprospan in people with Adrenal Cortex Hormones and Arthroplasty, Replacement, Knee, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
This study aims to compare the efficacy of different doses of glucocorticoids in local infiltration analgesia (LIA) during total knee arthroplasty (TKA) through a prospective single-center randomized controlled trial, and to explore the safety and feasibility of high-dose glucocorticoids. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Adrenal Cortex Hormones, Arthroplasty, Replacement, Knee, Anesthesia, Local
- What is being tested?
- LIA with different doses of Diprospan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants aged 18 years or older;
- Undergoing primary unilateral total knee arthroplasty (TKA)for unilateral knee osteoarthritis(OA)at ourhospital;
- Preoperative American Society of Anesthesiologists(ASA)physical status classification of 1-3;
- Ability to provide informed consent and sign a written informed consent form.
Who cannot join
- Previous surgery on the operative knee or a history of infection in the operative knee;
- Non-osteoarthritis conditions (including rheumatoid arthritis, traumatic arthritis, septic arthritis, and hemophilic arthritis);
- Severe osteoarthritis (including flexion contracture >30° or varus/valgus deformity >30°);
- Allergy to the relevant study drugs;
- Presence of neuromuscular dysfunction in the ipsilateral limb;
- Dependence on anesthetic drugs (defined as weekly use of opioids exceeding 100 mg morphine equivalents or local anesthetics for preoperative pain control for more than 3 months);
- Poor systemic condition, including but not limited to: glycated hemoglobin (HbA1c) level >12%; blood pressure >170/110 mmHg (1 mmHg = 0.133 kPa); history of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure, or any acute coronary event within 6 months; dialysis or renal transplantation; pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004
Chaofan Zhang, PhD, +86059187982113, drcfzhang@fjmu.edu.cn
About this study
Official title: Prospective Randomized Controlled Trial Comparing Different Doses of Corticosteroids in Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty
This study aims to compare the efficacy of different doses of glucocorticoids in local infiltration analgesia (LIA) during total knee arthroplasty (TKA) through a prospective single-center randomized controlled trial, and to explore the safety and feasibility of high-dose glucocorticoids. Through this research, the investigators hope to provide an optimized solution for post-TKA pain management, improve patients' postoperative recovery and quality of life, and offer scientific evidence for pain management following TKA.
- Being tested
- LIA with different doses of Diprospan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIA with different doses of DiprospanDrug
LIA with different doses of Diprospan
| Study group | Role | What they receive |
|---|---|---|
| High-dose group | Experimental | LIA with the addition of 3 vials of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg) Receives: Drug: LIA with different doses of Diprospan |
| Medium-dose group | Experimental | LIA with the addition of 2 vials of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg) Receives: Drug: LIA with different doses of Diprospan |
| Low-dose group | Experimental | LIA with the addition of 1 vial of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg) Receives: Drug: LIA with different doses of Diprospan |
| Control group | No intervention | LIA without the addition of Diprospan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Pain Score
VAS ranges from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain.
Measured: Preoperatively (baseline), and at 6 hours, 12 hours, 24 hours, 48 hours, 3 weeks, and 6 weeks postoperatively.
Secondary outcomes (12)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Patient-reported outcome measuring pain, stiffness, and physical function in knee osteoarthritis. Total score ranges from 0 (best) to 96 (worst). Lower scores indicate better outcomes.
Measured: Preoperatively, and at 3 weeks and 6 weeks postoperatively.
range of motion
The range of motion (flexion and extension) of the operated knee will be measured using a standard goniometer. The primary outcome is the maximum active flexion angle (in degrees). A greater range of motion indicates better functional recovery.
Measured: Preoperatively, and at 3 weeks and 6 weeks postoperatively.
Total Postoperative Analgesic Consumption
The total consumption of all analgesic medications administered for postoperative pain control. All doses will be converted to morphine milligram equivalents (MME) for opioids (e.g.,tramadol) and to standardized dosages for non-opioid analgesics (e.g., ibuprofen, celecoxib, acetaminophen). The outcome will be reported as total MME (for opioids) and total standardized dosage (for non-opioids), both as continuous measures.
Measured: Within the first 48 hours postoperatively
. C-reactive Protein (CRP) Concentration
Serum CRP level measured in milligrams per liter (mg/L). A key marker of systemic inflammation.
Measured: Postoperative Day 1, Day 4, Week 3, and Week 6.
Erythrocyte Sedimentation Rate (ESR)
Erythrocyte sedimentation rate measured in millimeters per hour (mm/h). A nonspecific marker of inflammation.
Measured: Postoperative Day 1, Day 4, Week 3, and Week 6.
interleukin-6(IL-6)
Serum IL-6 level measured in picograms per milliliter (pg/mL). A pro-inflammatory cytokine.
Measured: Postoperative Day 1, Day 4, Week 3, and Week 6.
Alanine Aminotransferase (ALT) Concentration
Serum ALT level measured in units per liter (U/L). Elevated levels may indicate liver injury.
Measured: Postoperative Day 1, Day 4, Week 3, and Week 6.
Aspartate Aminotransferase (AST) Concentration
Serum AST level measured in units per liter (U/L). Elevated levels may indicate liver or muscle injury.
Measured: Postoperative Day 1, Day 4, Week 3, and Week 6.
Serum Creatinine Concentration
Serum creatinine level measured in micromoles per liter (μmol/L). Elevated levels may indicate impaired renal function.
Measured: Postoperative Day 1, Day 4, Week 3, and Week 6.
Blood Urea Nitrogen (BUN) Concentration
Blood urea nitrogen level measured in millimoles per liter (mmol/L). Elevated levels may be associated with dehydration or renal dysfunction.
Measured: Postoperative Day 1, Day 4, Week 3, and Week 6.
Incidence of Local Complications
The incidence of postoperative local complications at the surgical site, including but not limited to: wound exudation, poor wound healing, and periprosthetic joint infection. Incidence is defined as the number of participants experiencing at least one local complication, divided by the total number of participants in each group, expressed as a percentage.
Measured: 0-6 months postoperatively
Incidence of Systemic Complications
The incidence of postoperative systemic complications, including but not limited to: nausea, vomiting, deep vein thrombosis (DVT), and acute liver failure. Incidence is defined as the number of participants experiencing at least one systemic complication, divided by the total number of participants in each group, expressed as a percentage.
Measured: 0-6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal Cortex HormonesStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337772
- Sponsor's protocol ID
- QT2025013-ZX
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Comparing Different Doses of Corticosteroids in Local Infiltration Analgesia (LIA) for Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07337772
- Acronym / sponsor ID
- QT2025013-ZX
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 13 Jan 2026 (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.
This study aims to compare the efficacy of different doses of glucocorticoids in local infiltration analgesia (LIA) during total knee arthroplasty (TKA) through a prospective single-center randomized controlled trial, and to explore the safety and feasibility of high-dose glucocorticoids. Through this research, the investigators hope to provide an optimized solution for post-TKA pain management, improve patients' postoperative recovery and quality of life, and offer scientific evidence for pain management following TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-dose group | Experimental | Drug: LIA with different doses of DiprospanLIA with the addition of 3 vials of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg) |
| Medium-dose group | Experimental | Drug: LIA with different doses of DiprospanLIA with the addition of 2 vials of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg) |
| Low-dose group | Experimental | Drug: LIA with different doses of DiprospanLIA with the addition of 1 vial of Diprospan (each vial contains betamethasone 5 mg + betamethasone dipropionate 2 mg) |
| Control group | No intervention | –LIA without the addition of Diprospan |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participants aged 18 years or older;
- Undergoing primary unilateral total knee arthroplasty (TKA)for unilateral knee osteoarthritis(OA)at ourhospital;
- Preoperative American Society of Anesthesiologists(ASA)physical status classification of 1-3;
- Ability to provide informed consent and sign a written informed consent form.
Key exclusion criteria (7 listed)
- Previous surgery on the operative knee or a history of infection in the operative knee;
- Non-osteoarthritis conditions (including rheumatoid arthritis, traumatic arthritis, septic arthritis, and hemophilic arthritis);
- Severe osteoarthritis (including flexion contracture >30° or varus/valgus deformity >30°);
- Allergy to the relevant study drugs;
- Presence of neuromuscular dysfunction in the ipsilateral limb;
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 |
|---|---|---|
| LIA with different doses of DiprospanLIA with different doses of Diprospan | Drug | High-dose group, Low-dose group, Medium-dose group |
Primary outcome
Visual Analog Scale (VAS) Pain Score
Time frame: Preoperatively (baseline), and at 6 hours, 12 hours, 24 hours, 48 hours, 3 weeks, and 6 weeks postoperatively.
VAS ranges from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate worse pain.
12 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
Time frame: Preoperatively, and at 3 weeks and 6 weeks postoperatively.
range of motion
Time frame: Preoperatively, and at 3 weeks and 6 weeks postoperatively.
Total Postoperative Analgesic Consumption
Time frame: Within the first 48 hours postoperatively
. C-reactive Protein (CRP) Concentration
Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.
Erythrocyte Sedimentation Rate (ESR)
Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.
interleukin-6(IL-6)
Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.
Alanine Aminotransferase (ALT) Concentration
Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.
Aspartate Aminotransferase (AST) Concentration
Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.
Serum Creatinine Concentration
Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.
Blood Urea Nitrogen (BUN) Concentration
Time frame: Postoperative Day 1, Day 4, Week 3, and Week 6.
Incidence of Local Complications
Time frame: 0-6 months postoperatively
Incidence of Systemic Complications
Time frame: 0-6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIA with different doses of Diprospan in people with Adrenal Cortex Hormones and Arthroplasty, Replacement, Knee, run by First Affiliated Hospital of Fujian Medical University 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 Jan 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chaofan Zhang, PhD (+86059187982113, drcfzhang@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Pain Score (time frame: Preoperatively (baseline), and at 6 hours, 12 hours, 24 hours, 48 hours, 3 weeks, and 6 weeks postoperatively.). 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 13 Jan 2026.