Evaluation of Dexketoprofen in Total Knee Arthroplasty

Study Overview
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Brief Summary
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Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions. Dexketoprofen is a new NSAID treating acute postoperative pain. The purpose of this study is to evaluate the analgesic effect when it is given intravenously or as part of the local infiltration analgesia in patients under spinal anesthesia undergoing unilateral total knee arthroplasty.

Official Title
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Evaluation of Dexketoprofen Given Intravenous or Intrathecal in Postoperative Pain in Patients Undergoing Total Knee Arthroplasty

Conditions
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Postoperative Pain, Analgesia

Intervention / Treatment
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* Drug: Dexketoprofen Trometamol
* Drug: Ropivacaine Hydrochloride 7.5 MG/ML


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral total knee arthroplasty accept to enter the study ASA score I or II hospitalization for at least 2 days Exclusion Criteria: allergy in any given medications active gastrointestinal bleeding or other active bleeding history of peptic ulcer renal failure hepatic failure chronic heart failure
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Group IV<br>Dexketoprofen 50mg is given intravenous 10 min before the start of the surgery. Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine. | Drug: Dexketoprofen Trometamol<br>* intravenous dexketoprofen 50mg or intrathecal<br>Drug: Ropivacaine Hydrochloride 7.5 MG/ML<br>* Local Infiltration Analgesia<br>|
| Active Comparator: Group Periarticular<br>Dexketoprofen 50mg is given as part of the local infiltration analgesia with 300mg ropivacaine. Local infiltration analgesia is proceeded by the orthopedic surgeon. | Drug: Dexketoprofen Trometamol<br>* intravenous dexketoprofen 50mg or intrathecal<br>Drug: Ropivacaine Hydrochloride 7.5 MG/ML<br>* Local Infiltration Analgesia<br>|
| Placebo Comparator: Group P<br>Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine. | Drug: Ropivacaine Hydrochloride 7.5 MG/ML<br>* Local Infiltration Analgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Score in 8hours after surgery | The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. 10 describes the worst pain that a person ever imagined. | 8h | 
| VAS Score 24hours after surgery | The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. | 24h | 
| VAS Score 48hours after surgery | The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. | 48h | 
| Total tramadol consumption the first 24hours |  | 24h |