A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

Inclusion criteria

• Females 18 -70 years
• Elective, non-malignant laparoscopic gynecological surgery in general anesthesia : hysterectomy/ myomectomy, ASA 1, 2 and 3
• Subjects willing and able to participate the study and have provided informed consent form -

Exclusion criteria

• Previous recent or regular opioid use (WHO step I pain treatment allowed)
• Any situation where opioids are contraindicated.
• Any history of moderate to severe hepatic impairment.
• Any history of severe respiratory depression with hypoxia and/or hypercapnia
• Any history of severe chronic obstructive pulmonary disease, cor pulmonal, acute severe bronchial asthma
• Subjects with evidence of non-opioid induced paralytic ileus
• Subjects with evidence of severely impaired pulmonary function, myxoedema, hypothyroidism
• Subjects with evidence of Addison's disease (adrenal cortical insufficiency), toxic psychosis,cholelithiasis, prostate hypertrophy, alcoholism, delirium, pancreatitis, hypotension, hypertension, pre-existing cardiovascular diseases, head injury (due to the risk of increased intracranial pressure), epileptic disorder or predisposition to convulsions, or patients taking MAO inhibitors.
• Any history of hypersensitivity to Oxycodone / Naloxone or to any of the excipients.
• Active alcohol or drug abuse and/or history of opioid abuse.
• Subjects with evidence of clinically unstable disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the Investigator's opinion, preclude entry into the study.
• Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period).