Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery (oksineukir)

Kuopio University Hospital

Status and phase: Completed; Phase 4

Conditions: Constipation

Treatments: Drug: oxycodone-naloxone; Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT02573922

KUH24-02-2012

Details and patient eligibility

About

In the present study, the primary aim was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced opioid induced constipation in patients with or without chronic opioid treatment undergoing spine surgery.

Enrollment: 180 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI 17 - 35 kg/m2
• elective spine surgery
• informed consent obtained

Exclusion criteria

• allergy to the used drugs
• other contraindication to oxycodone medication
• no informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Oxycodone-naloxone

Experimental group

Description:

Oxycodone-naloxone prolonged release tablet twice a day

Treatment:

Drug: oxycodone-naloxone

Oxycodone

Active Comparator group

Description:

Oxycodone prolonged release tablet twice a day

Treatment:

Drug: Oxycodone