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

Phase 4

Completed

• Conditions: Postoperative Pain; Opioid Related Disorders
• Interventions: Drug: Prolonged-release oxycodone/naloxone; Drug: Oxycodone

• Registration Number: NCT01374763
• Lead Sponsor: Kati Järvelä

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-16
• Study Start: 2011-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-17
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• Adult cardiac surgery patient

Exclusion Criteria

• Preoperative continuous use of laxatives
• Known anatomic or functional gastrointestinal disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxycodone/naloxone	Prolonged-release oxycodone/naloxone	Prolonged-release oxycodone/naloxone
Oxycodone	Oxycodone	Drug: prolonged-release oxycodone

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Need of laxatives postoperatively	Participants will be followed for the duration of hospital stay, an expected average of 5 days

Trial Locations

Locations (1)

Tampere University Hospital Heart Center; 🇫🇮 Tampere, Finland