A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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Objectives: Primary objective: To demonstrate that the treatment with OXN PR tablets up to 72 hrs after surgery is superior to the treatment with OxyPR with regards to constipation in subjects with postoperative pain after laparoscopic hysterectomy based on interviews 24h, 72 h and 1 week postoperatively. The secondary objectives: Analgesic effect (including registration during the first 24 hrs) To asses the frequency of pain rescue mediation use (in the double-blind phase, 0-72 hrs) Frequency of nausea and vomiting Frequency of other adverse events Appetite Mobilization The exploratory objectives: Overall patient satisfaction at 24, 72 hrs and 1 week

Conditions
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Postoperative Pain, Opioid Induced Constipation

Intervention / Treatment
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* Drug: naloxone
* Drug: oxycodone


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oxycodone+naloxone<br> | Drug: naloxone<br> <br> Drug: oxycodone<br> <br> |
| Active Comparator: Control<br>Oxycodone alone without naloxone | Drug: oxycodone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constipation in subjects with postoperative pain |  | 3 days |