Combination of Continuous Femoral Block and Intravenous Parecoxib For Postoperative Analgesia After Total Knee Arthroplasty

Study Overview
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Brief Summary
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Combination of continuous femoral block with parEcoxib vs placebo. Investigation of morphine consumption, opioid sparing effects, VAS pain scores, haemodynamics, Anxierty scores, transfusion requirements , Range of motion and rehabilitation parameters between two groups

Official Title
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COMBINATION OF CONTINUOUS FEMORAL BLOCK AND INTRAVENOUS PARECOXIB FOR POSTOPERATIVE ANALGESIA AFTER TOTAL KNEE ARTHROPLASTY. A DOUBLE BLIND PROSPECTIVE STUDY.

Conditions
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POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFB

Intervention / Treatment
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* Drug: Parecoxib
* Drug: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%
* Drug: N/S 0.9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PATIENTS ASA I-II UNDERGOING TOTAL KNEE ATRTHROPLASTY Exclusion Criteria: Exclusion criteria for both groups included: Age younger than 40 years old or older than 80 years old ASA > III Obesity (>140 kg body weight) Allergy to local anesthetics History dependence on opioids Contraindications for subarachnoid anesthesia or femoral block (coagulopathy, local infection, pre-existing neurological problems, patient refusal) Contraindications to the administration of parecoxib Severe hepatic or renal disease (serum creatinine ≥ 1.7 mg/dl)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CONTINUOUS FEMORAL BLOCK AND PARECOXIB<br>Continuous infusion of0,2% of ropivacaine at 10 ml/h and 2 mls (40 mg) of iv parecoxib | Drug: Parecoxib<br> <br> * Other names: DYNASTAT;Drug: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%<br> <br> * Other names: NAROPEINE;|
| Placebo Comparator: CONTINUOUS FEMORAL BLOCK AND PLACEBO<br>Continuous infusion of 0.2% ropivacaine at 10 ml/h and 2 mls of iv N/S0.9% | Drug: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%<br> <br> * Other names: NAROPEINE;Drug: N/S 0.9%<br> <br> * Other names: PLACEBO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS |  | 36/h POSTOPERATIVELY | 
| VAS PAIN SCORES BETWEEN TWO GROUPS |  | 36/h POSTOPERATIVELY | 
| HAEMODYNAMIC PARAMETERS BETWEEN TWO GROUPS |  | During perioperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ANXIETY LEVELS | ANXIETY SCORES WERE QUANTIFIED USING THE SPIELBERG INVENTORY | 36 HOURS POSTOPERATIVELY | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PARECOXIB, CONTINUOUS FEMORAL BLOCK