Parecoxib for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty

Study Overview
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Brief Summary
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Evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.

Detailed Description
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Non-steroid anti-inflammatory drugs are recommended for multimodal postoperative pain management. We evaluated the effect of perioperative parecoxib administration on postoperative pain, analgesic use, function recovery, inflammatory response and bleeding risk.

Official Title
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Perioperative Parecoxib Administration for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty-A Randomized, Placebo-controlled Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Parecoxib sodium
* Drug: Normal saline injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients who have underwent primary unilateral total knee arthroplasty (TKA) and total hip arthroplasty (THA). Age between 18-65 years. Chinese ethnicity. Exclusion Criteria: patients who underwent a reversion or a previous TKA or THA, emergency TKA, or TKA as result of a trauma. patient exhibited allergy to parecoxib sodium. lactating or pregnant. any other conditions not suitable for surgery as evaluated by the surgeon in charge.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parecoxib sodium<br>The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision. | Drug: Parecoxib sodium<br>* The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.<br>* Other names: Dynastat;|
| Placebo Comparator: Normal saline injection<br>The control group received 2 mL normal saline injection at the same time point. | Drug: Normal saline injection<br>* The patients in the control group received 2 mL normal saline injection 30 minutes before Normal saline injection incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.<br>* Other names: Physiological saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the Morphine consumption in each group patients |  | 4 hours to 6 days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate Patient-Controlled Intravenous Analgesia (PCIA) duration |  | 4 hours to 6 days after the surgery | 
| To evaluate the Visual Analog Scale (VAS) in each group patients underwent total knee arthroplasty and total hip arthroplasty |  | 4 hours to 6 days after the surgery | 
| Function recovery of knee Range of Motion (ROM) for patients received surgery |  | 3 and 6 days after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preemptive analgesia, parecoxib sodium, total knee arthroplasty, total hip arthroplasty