Postoperative analgesia with continuous epidural bupivacaine/sufentanil versus bupivacaine/morphine in patients scheduled for major surgery.

INTERVENTION: Product Name: bupivacaine/ sufentanyl Pharmaceutical Form: Injection* INN or Proposed INN: BUPIVACAINE CAS Number: 2180929 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2.5‐ INN or Proposed INN: SUFENTANIL CAS Number: 56030547 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 1‐ Product Name: bupivacaine/ morphine Pharmaceutical Form: Injection* INN or Proposed INN: BUPIVACAINE CAS Number: 2180929 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2.5‐ INN or Proposed INN: MORPHINE CAS Number: 57272 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0,08‐ CONDITION: Pain scores and side‐effects of the epidural analgesia ; MedDRA version: 9.1 Level: LLT Classification code 10033371 Term: Pain PRIMARY OUTCOME: Main Objective: Pain scores Primary end point(s): VAS pain scores. Secondary Objective: Side‐effects: nausea, vomiting, pruritus, sedation, motorblok and patient satisfaction. INCLUSION CRITERIA: All patients > ‐ 18 years old, scheduled for major surgery and indicated for epidural catheter. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range