Patients subjects at VATS for spontaneus pneumothorax MedDRA version: 9.1 Level: LLT Classification code 10062043 Term: Lung operation
Conditions
Interventions
Trade Name: OXYCONTIN*28CPR 20MG R.P.
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Oxycodone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2
Sponsors
AZIENDA OSPEDALIERA DI PARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Patients scheduled for Video-assisted thoracoscopic surgery for spontaneous pneumothorax · Age between 18 and 65 years · ASA status I-II 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · ASA status ≥ III · Documented myocardial infarction in the previous 6 months · Renal insufficiency (creatinine > 2mg/dl) · Uncontrolled hypertension · BMI>30 · Psychiatric disorders · Actual or suspected pregnancy · Allergy to NSAIDs or to other protocol drugs · Anaemia · Epilepsy · Family history or previous history of malignant hyperthermia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Difference in total morphine consumption at 48 hours between groups.;Secondary Objective: Difference in length of stay in recovery room between groups. Difference in Visual Analogue Scale Scores recorded 1 hour after the end of surgery between groups.;Primary end point(s): Difference in total morphine consumption at 48 hours between groups. | — |
Countries
Italy
Outcome results
None listed