Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess efficacy and safety of lornoxicam compared with that of etoricoxib after total knee replacement.

Detailed Description
-----------------
Total primary knee arthroplasty (TKA) remains a model of severe pain for major orthopedic surgery. The concept of multimodal analgesia for the postoperative pain therapy is a routine in many hospitals but the question is still under debate about the ideal combination between techniques and drugs regarding early mobilization and low risk of complications. After obtaining Ethical Committee approval and informed consent, 110 patients American Society of Anesthesiologists score (ASA ) I-II undergoing knee replacement under spinal anesthesia were randomized to receive postoperative either lornoxicam (8 mg per os (PO) /12 hours (h) for 48 h) or etoricoxib (120mg PO/24 h for 48 h) both administered in the postoperative care unit, at the end of surgery. The groups received postoperative analgesia when Numeric Rating Scale (NRS) over 3 with IV Perfalgan in fixed dose 1g every 8 h and morphine (loading dose 0,1mg/kg and titration until NRS under 3, followed by subcutaneous (SC) administration of ½ of the total loading dose on demand for the following 48 h).The lornoxicam group received gastric protection with IV pantoprazole. The effectiveness was evaluated by the time from the initiation of spinal anesthesia until the first analgesic dose at NRS over 3, the total amount of morphine in the first 24 and 48 h postoperative, the side effects and necessary amount of adjuvant medication.

Official Title
-----------------
A Comparative Study of Efficacy and Safety of Lornoxicam Versus Etoricoxib After Total Knee Arthroplasty

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Lornoxicam
* Drug: Etoricoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-III weight (kilos) over 40 kg height (centimeters) over 155 cm non-anemic indication for primary TKA Exclusion Criteria: history of asthma peptic ulcer severe hepatic or renal dysfunction neuropathies bleeding disorders uncooperative drugs abuse sensibility to the drugs used 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
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GROUP LORNOXICAM<br>Immediately in postoperative care unit patients received lornoxicam 8 mg PO/12 hours for 48 hours | Drug: Lornoxicam<br>* At the end of surgery patients in group LORNOXICAM received one pill of 8 mg lornoxicam every 12 hours in the surgery day and first postoperative day.<br>* Other names: XEFO;|
| Active Comparator: GROUP ETORICOXIB<br>Immediately in postoperative care unit patients received etoricoxib 120 mg PO and another pill at 24 hours. | Drug: Etoricoxib<br>* At the end of surgery patients in the ETORICOXIB group received one pill of 120 mg etoricoxib at the end of surgery and a second one after 24 hours. This group also received placebo pills at 12 h, between the active pills.<br>* Other names: Tauxib;|

What is the study measuring?
-----------------
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 hours 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 | At 48 hours postoperative | 
| Duration of analgesia | Time from spinal anesthesia until the first rescue morphine analgesia | At 48 hours postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain, lornoxicam, etoricoxib, total knee arthroplasty