Analgesic Benefit of Preoperative vs. Postoperative Etoricoxib in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib in total knee arthroplasty (TKA).

Detailed Description
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The investigators conducted a prospective randomized controlled study in 165 patients American Society of Anesthesiologists (ASA) score I-III scheduled for primary TKA, divided in 3 groups: group A (Etoricoxib 120 mg orally one hour before surgery), group B (Etoricoxib 120 mg orally at the end of surgery) and group C placebo. Surgery has been performed under spinal anesthesia. All groups received postoperative analgesia when Numeric Rating Scale (NRS) over 3 with intravenous (IV) Perfalgan and morphine on demand for the following 48 h. The effectiveness was evaluated by the time from the initiation of spinal anesthesia until the first analgesic dose at NRS > 3, the total amount of morphine in the first 24 and 48 hours postoperative, the side effects and necessary amount of adjuvant medication.

Official Title
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Is There Any Analgesic Benefit From Preoperative vs. Postoperative Etoricoxib Administration in Total Knee Arthroplasty?

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Etoricoxib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III weight (kilos) over 40 kg height (centimeters) over 155 cm non-anemic indication for primary TKA (total knee arthroplasty) Exclusion Criteria: history of asthma peptic ulcer severe hepatic or renal dysfunction neuropathies bleeding disorders uncooperative drug abuse sensibility to etoricoxib paracetamol or morphine long acting nonsteroidal antiinflammatory drugs (NSAID) in the last 4 days preoperative cerebrovascular and peripheric vascular disease arterial hypertension (HTA) not adequately controlled congestive heart failure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group ETORICOXIB PREOP<br>Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery. | Drug: Etoricoxib<br>* 120 mg etoricoxib PO administered 1 h preoperative for group A; group B received 120 mg etoricoxib PO at the end of the surgery.<br>* Other names: Etozox;Drug: Placebo<br>* Group A received 1 sham pill PO at the end of the surgery; group B received 1 sham pill PO 1 h preoperative and group C received sham pill PO 1 h preoperative and 1 sham pill PO at the end of the surgery.<br>* Other names: Sham pill;|
| Experimental: Group ETORICOXIB POSTOP<br>Preoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia). | Drug: Etoricoxib<br>* 120 mg etoricoxib PO administered 1 h preoperative for group A; group B received 120 mg etoricoxib PO at the end of the surgery.<br>* Other names: Etozox;Drug: Placebo<br>* Group A received 1 sham pill PO at the end of the surgery; group B received 1 sham pill PO 1 h preoperative and group C received sham pill PO 1 h preoperative and 1 sham pill PO at the end of the surgery.<br>* Other names: Sham pill;|
| Placebo Comparator: Group PLACEBO<br>1 placebo pill PO 1 h preoperative and 1 placebo pill PO postoperative at the end of surgery. | Drug: Placebo<br>* Group A received 1 sham pill PO at the end of the surgery; group B received 1 sham pill PO 1 h preoperative and group C received sham pill PO 1 h preoperative and 1 sham pill PO at the end of the surgery.<br>* Other names: Sham pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption | Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3 | At 48 hour postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with side effects of drugs used | number of patients with postoperative nausea and vomiting (PONV) or respiratory depression or gastric complaint or allergic reactions | 48 hour postoperative | 
| Duration of analgesia | Time from spinal anesthesia until the first rescue morphine analgesia | At 48 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preemptive, postoperative pain, etoricoxib