A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery

Study Overview
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Brief Summary
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The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. The hypothesis is that the duration of opioid-induced bowel dysfunction and the need of laxatives will decrease.

Detailed Description
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Opioid-induced bowel dysfunction is common in cardiac surgery patients postoperatively. Opioids are needed to treat severe postoperative pain, but they have troublesome side-effects such as nausea, vomiting and bowel dysfunction. These symptoms also limit the use of gastrointestinal tract for nutrition and medication. Combined prolonged-releases oxycodone and naloxone has been shown to provide as effective analgesia as PR oxycodone. Oxycodone/naloxone has also been suggested to improve bowel function without compromising analgesic efficacy. The aim of the study is to describe the effects of oxycodone/naloxone combination in comparison to oxycodone for the treatment of postoperative pain in patients undergoing cardiac surgery. During the first three months of the study, all cardiac surgery patients will be treated with PR oxycodone. During the second part of the study (3 months), all cardiac surgery patients will be treated with PR oxycodone/naloxone. The primary end point is the duration of opioid-induced bowel dysfunction. Need of laxatives will be recorded.

Official Title
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A Comparison of PR Oxycodone/Naloxone and PR Oxycodone After Cardiac Surgery

Conditions
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Opioid Related Disorders, Postoperative Pain

Intervention / Treatment
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* Drug: Oxycodone
* Drug: Prolonged-release oxycodone/naloxone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult cardiac surgery patient Exclusion Criteria: Preoperative continuous use of laxatives Known anatomic or functional gastrointestinal disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxycodone<br>Drug: prolonged-release oxycodone | Drug: Oxycodone<br>* Prolonged-release oxycodone 10-30 mg twice daily<br>|
| Active Comparator: Oxycodone/naloxone<br>Prolonged-release oxycodone/naloxone | Drug: Prolonged-release oxycodone/naloxone<br>* Prolonged-release oxycodone/naloxone 10-30 mg twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of opioid-induced bowel dysfunction postoperatively |  | Participants will be followed for the duration of hospital stay, an expected average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need of laxatives postoperatively |  | Participants will be followed for the duration of hospital stay, an expected average of 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Naloxone, Oxycodone, Constipation, Pain, postoperative, Physiological effects of drugs, Analgesics, Opioid