A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

Inclusion Criteria:

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

Exclusion Criteria:

1. Previous recent or regular opioid use (WHO step I pain treatment allowed)
2. Any situation where opioids are contraindicated.
3. Any history of moderate to severe hepatic impairment.
4. Any history of severe respiratory depression with hypoxia and/or hypercapnia
5. Any history of severe chronic obstructive pulmonary disease, cor pulmonal, acute severe bronchial asthma
6. Subjects with evidence of non-opioid induced paralytic ileus
7. Subjects with evidence of severely impaired pulmonary function, myxoedema, hypothyroidism
8. 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.
9. Any history of hypersensitivity to Oxycodone / Naloxone or to any of the excipients.
10. Active alcohol or drug abuse and/or history of opioid abuse.
11. 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.
12. Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period).