Comparison of the analgesic effects of bupivacaine, at different doses administered via a thoracic paravertebral catheter, and its implications for pulmonary function in patients undergoing thoracotomy for pulmonary resection surgery

INTERVENTION: Trade Name: BUPIVACAINE INJECTABLE BRAUN 0.50% miniplasco Pharmaceutical Form: Suspension for injection INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE CAS Number: 18010-40-7 Other descriptive name: BUPIVACAINE HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/milliliter Concentration type: equal Concentration number: 5- CONDITION: Patients undergoing thoracotomy for pulmonary resection surgery; MedDRA version: 13 Level: LLT Classification code 10002708 Term: Anterior thoracotomy PRIMARY OUTCOME: Main Objective: To compare postoperative pain at 8, 24, 48, and 72 hours post-extubation Primary endpoint(s): Outcome: Pain, pulmonary function, sensory block, motor block, hypoxemia, and adverse effects Secondary Objective: To compare pulmonary function and sensory and motor block at 8, 24, 48, and 72 hours; to compare the incidence of cardiotoxicity and neurotoxicity; to compare mean daily opioid consumption INCLUSION CRITERIA: ASA group I, II, or III; BMI greater than 20 and less than 30; Height >150 cm; Age >18 and <70 years; Signed Informed Consent; FEV1 and DLCO >80% of predicted; FEV1>1.5L for lobectomy and >2 for pneumonectomy; stop smoking at least 8 weeks before 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 F.1.3 Elderly (>=65 years) no