Comparing three ways of using parecoxib for pain relief after total knee arthroplasty
| ISRCTN | ISRCTN10410133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10410133 |
| Sponsor | Luoyang Orthopedic-Traumatological Hospital of Henan Province |
| Funder | Investigator initiated and funded |
- Submission date
- 12/05/2026
- Registration date
- 13/05/2026
- Last edited
- 12/05/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Knee osteoarthritis is a common chronic joint disease that causes pain and difficulty in movement. Total knee arthroplasty (TKA) is an effective treatment for advanced knee osteoarthritis, but postoperative pain management remains a challenge. Parecoxib sodium is a commonly used analgesic. This study aims to compare the effects of three different routes of administration (intravenous, intra‑articular, and intraosseous tibial injection) on reducing postoperative opioid consumption and relieving pain, with a particular focus on whether intraosseous injection offers greater advantages.
Who can participate?
Adults aged 50–75 years with knee osteoarthritis scheduled for total knee arthroplasty
What does the study involve?
Participants will be randomly assigned to three groups. The three groups will receive parecoxib sodium (40 mg/20 ml) via the following routes during surgery:
1. Intravenous injection (into a vein)
2. Intra-articular injection (into a joint).
3. Intraosseous (tibial) injection (into the shin bone)
Apart from the different intervention routes, all three groups will receive identical surgical, anesthetic, basic analgesic, and rehabilitation protocols.
What are the possible benefits and risks of participating?
Participants may achieve better postoperative pain control and earlier rehabilitation; the study results may help improve analgesic strategies for future patients.
Parecoxib sodium is generally well tolerated, but mild gastrointestinal discomfort or allergic reactions may occur. In rare cases, bleeding or infection at the injection site may happen. The research team will closely monitor and manage any adverse events.
Where is the study run from?
Luoyang Orthopedic Hospital of Henan Province (Orthopedic Hospital of Henan Province) (China)
When is the study starting and how long is it expected to run for?
May 2026 to October 2027
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Liu Xiaoya, 743229210@qq.com
Contact information
Public
No. 82, Qiming South Road
Luoyang
471002
China
| Phone | +86 (0)17836931893 |
|---|---|
| 743229210@qq.com |
Scientific
No. 82, Qiming South Road
Luoyang
471002
China
| Phone | +86 (0)13526976381 |
|---|---|
| Orthopedics.Yue@outlook.com |
Principal investigator
No. 82, Qiming South Road
Luoyang
471002
China
| Phone | +86 (0)15838537825 |
|---|---|
| zouchunyu117@163.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Analgesic effect of intraosseous parecoxib sodium injection during total knee arthroplasty: a single-center, three-arm, randomized controlled trial |
| Study objectives | This study aims to determine whether intraosseous (tibial) injection of parecoxib sodium can more effectively reduce postoperative opioid consumption and alleviate postoperative pain after total knee arthroplasty (TKA) compared with conventional intravenous and intra-articular injections. |
| Ethics approval(s) |
Approved 10/04/2026, Medical Ethics Committee of Henan Luoyang Orthopedic-Traumatological Hospital (Henan Province Orthopedic Hospital) (No. 82, Qiming South Road, Luoyang, 471002, China; +86 (0)379-63546181; hnslyzgyyllwyh@aliyun.com), ref: 2026ZXKT0001-02 |
| Health condition(s) or problem(s) studied | Patients with knee osteoarthritis who require total knee arthroplasty |
| Intervention | This study aims to compare the analgesic effects of three different administration routes of parecoxib sodium during total knee arthroplasty (TKA). Except for the specific routes described below, all three groups of participants will receive identical surgical procedures, basic analgesia, rehabilitation protocols, and other perioperative management strategies. The details are as follows: In each group, the drug is 40 mg of injectable parecoxib sodium (Emeishan Tonghui Pharmaceutical Co., Ltd., specification: 20 mg per vial), diluted to 20 ml with 0.9% normal saline. The specific administration protocols are as follows: 1. Intravenous injection group: Before inflation of the lower extremity tourniquet, an anesthesiologist slowly injects the 20 ml parecoxib dilution through an intravenous line, ensuring the drug enters the systemic circulation before the limb circulation is blocked, thereby achieving systemic distribution. 2. Intra‑articular injection group: Before prosthesis implantation, the 20 ml parecoxib dilution is injected with a syringe into multiple pain targets, including the intra‑articular space, posterior capsule, attachment points of the medial and lateral collateral ligaments, the insertion of the quadriceps tendon, and the peri‑articular soft tissues. This allows the drug to remain in the local tissues and exert its analgesic effect while minimizing systemic exposure. 3. Intraosseous injection group: After arthrotomy and full exposure of the proximal tibia, but before the tibial cut, the following steps are performed: in the cancellous bone area approximately 1 cm medial or lateral to the tibial tuberosity, an injection cannula is inserted perpendicularly into the cancellous bone to a depth of about 1.5–2.0 cm. After confirming secure placement, a syringe is connected and the 20 ml parecoxib dilution is slowly injected. Upon needle withdrawal, gentle pressure is applied to the puncture site with bone wax or a gelatin sponge to seal the hole. The drug is then rapidly absorbed through the marrow sinusoids, initially achieving a very high local concentration in the surgical area and subsequently entering the systemic circulation rapidly. Random sequence generation: A member of the research team who is not involved in patient recruitment, intervention delivery, or outcome assessment will generate the random allocation sequence using SAS statistical software. Randomisation scheme: Stratified block randomisation with a 1:1:1 allocation ratio among the three groups will be used. Because the type of anaesthesia has a substantial impact on postoperative pain in patients undergoing total knee arthroplasty (TKA), anaesthesia type (general anaesthesia versus combined spinal epidural anaesthesia) will be used as a stratification factor to ensure balance between groups regarding this key prognostic factor. Within each stratum, variable block sizes (mixed 3/6/9) will be applied to maintain approximate balance in the number of patients assigned to the three treatment groups (intravenous, intra-articular, and intraosseous) at any timepoint during the study, while preventing the researcher from easily predicting the next allocation. Allocation concealment: To ensure strict implementation of randomisation, sequentially numbered, opaque, sealed envelopes will be used for allocation concealment. Each envelope will bear only a sequence number and stratification information (e.g., "GA 001" for general anaesthesia). The treatment group assignment will be written on a card inside the envelope. After patient enrolment and determination of the anaesthesia type, a team member not involved in subsequent treatment or outcome assessment will open the next envelope in sequence for the corresponding stratum and notify the surgical team of the allocation result. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Parecoxib sodium |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/10/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 171 |
| Key inclusion criteria | 1. Patients aged 50–75 years with a primary diagnosis of knee osteoarthritis 2. Patients scheduled for primary, elective, unilateral total knee arthroplasty without clear contraindications to surgery 3. American Society of Anesthesiologists (ASA) physical status classification I–III 4. Willing to participate in the study and able to provide written informed consent |
| Key exclusion criteria | 1. Body mass index (BMI) >35 kg/m² or body weight <50 kg 2. Presence of contraindications to parecoxib sodium, including: 2.1. Allergic reactions 2.2. History of gastrointestinal bleeding caused by NSAIDs 2.3. Inflammatory bowel diseases such as Crohn's disease or ulcerative colitis 2.4. Diagnosed coronary heart disease, lower extremity atherosclerosis, or cerebral atherosclerosis 3. Severe cardiac, hepatic, or renal insufficiency: 3.1. Cardiac function: New York Heart Association (NYHA) class III or IV, or acute myocardial infarction within the past 6 months 3.2. Hepatic function: Child-Pugh class B or C 3.3. Renal function: estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m² 4. Patients with inflammatory arthropathy, such as rheumatoid arthritis or ankylosing spondylitis 5. Local factors that significantly increase surgical complexity, trauma, or operative time (expected operative time >90 minutes), including: prior ipsilateral knee infection, history of complex fracture, previous periarticular osteotomy, massive periarticular bone defect, functional knee stiffness (preoperative maximum range of motion <50°); or severe deformity (varus >20°, valgus >15°, or flexion >20°) 6. Participation in another clinical trial within the past 6 months 7. Any surgical procedure within the past 3 months 8. Presence of cognitive impairment or psychiatric disorder that prevents compliance with study assessments |
| Date of first enrolment | 25/05/2026 |
| Date of final enrolment | 31/05/2027 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
12/05/2026: Study's existence confirmed by the Ethics Committee of Luoyang Orthopedic-Traumatological Hospital of Henan Province (Henan Provincial Orthopedic Hospital).
