valoración del control del dolor en la artroplastia total de rodilla con diferentes pautas de anestesia

INTERVENTION: Trade Name: Naropin Polyamp Product Name: ropivacaina Pharmaceutical Form: Concentrate and solvent for injection INN or Proposed INN: ropivacaine hydrocloride CAS Number: 0132112‐35‐7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: Naropin Polyamp Product Name: ropivacaina Pharmaceutical Form: Concentrate and solvent for injection INN or Proposed INN: ropivacaine hydrochloride CAS Number: 0132112‐35‐7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: Morfina clorhidrato 1% Product Name: morphine Pharmaceutical Form: Concentrate and solvent for injection INN or Proposed INN: morphine CAS Number: 0006055‐06‐7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Trade Name: Morfina clorhidrato 1% Product Name: morphine Pharmaceutical Form: Concentrate and solvent for injection INN or Proposed INN: morphine CAS Number: 0006055‐06‐7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Trade Name: Ketorolaco trometamol Product Name: ketorolac Pharmaceutical Form: Concentrate and solvent for injection INN or Proposed INN: ketorolac CAS Number: 0074103‐06‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ Trade Name: Ketorolaco trometamol Product Name: ketorolac Pharmaceutical Form: Concentrate and solvent for injection INN or Proposed INN: ketorolac CAS Number: 0074103‐06‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30‐ Trade Name: Adrenaline B. Braun Product Name: adrenaline Pharmaceutical Form: Concentrate and solvent for injection INN or Proposed INN: adrenaline CAS Number: 51‐43‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.3‐ Trade Name: Fisiológico Braun 0,9% Product Name: saline serum Pharmaceutical Form: Concentrate and solvent for injection INN or Proposed INN: saline CONDITION: artroplastia total de rodilla Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Surgical Procedures, Operative [E04] PRIMARY OUTCOME: Main Objective: Comparar la eficacia analgésica y funcional de tres técnicas: infiltración local en la zona de incisión con varios fármacos; bloqueo femoral; la combinación de las dos en la artroplastia total de rodilla (ATR). Primary end point(s): dolor y recuperación funcional Secondary Objective: ‐determinar los factores prequrúrgicos que pueden interferir en recuperación de la ATR; ‐determinar los factors relacionados con el procedimiento quirúrgico implicados en la recuperación funcional al alta y a los 6 meses; ‐estudiar la repercusión anímica y en calidad de vida de la población intervenida. Timepoint(s) of evaluation of this end point: en el momento de iniciar la rehabilitación SECONDARY OUTCOME: Secondary end point(s): ‐efectos adversos relacionados con las técnicas analgésicas; ; ‐grado de ansiedad, depresión y dolor prequirúrgico Timepoint(s) of evaluation of this end point: a las 48 horas INCLUSION CRITERIA: ‐pacientes pendientes de intervención de ATR primaria ‐pacientes ASA I,II,III ‐edad > 65 años Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 156