Postoperative pain management after heart valve surgery using parasternal block and PCA Oxycodone

INTERVENTION: Trade Name: Chirocaine 2,5 mg/ml Pharmaceutical Form: Injection CAS Number: 27262‐48‐2 Other descriptive name: LEVOBUPIVACAINE HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2,5‐ Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Infiltration CONDITION: Mitral or aortic valve disease ; MedDRA version: 17.1 Level: LLT Classification code 10049495 Term: Heart valve operation NOS System Organ Class: 100000004865 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: Patient undergoing elective mitral‐ or aortic valve surgery, performed under standard surgery and anesthesia, will be randomized to undergo either incisional infiltration of local anesthetic, parasternal block ( active treatment group) or infiltration of saline as placebo before wound closure. The purpose of the study is to test the hypothesis that parasternal block improves postoperative analgesia in cardiac surgical patients and their requirement of oxycodone is decreased. Primary end point(s): The use of oxycodone is at least 25% lesser in active treatment group than placebo group. Secondary Objective: Secondary objective is to test hypothesis that patients with incisional infiltration of local anesthetic have shorter awakenig time and hospitalization time. Also the hypothesis is that patient in active treatment group has less chronic postsurgical pain. Timepoint(s) of evaluation of this end point: 48 hours after operation. SECONDARY OUTCOME: Secondary end point(s): 1. The active treatment group has less pain after operation. ; 2. The active treatment group has shorter hospitalization time. ; 3. The active treatment group has less chronic postsurgical pain. Timepoint(s) of evaluation of this end point: 1. 1, 2, 3, 4, 8, 24, 48, 72 hours after operation ; 2. When patients hospitalization ends ; 3. 1 month and 6 months after operation INCLUSION CRITERIA: Patients with mitral‐ or aortic valve disease requiring elective isolated valve surgery. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44