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OpenTrials
Completed

NCT Number: NCT02573922

Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxycodone-naloxone

Drug

Oxycodone

Drug

Primary outcomes

  1. opioid induced constipation

    Time frame: from the surgery up to 21 days

    Opioid induced constipation was assessed with bowel function index

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Acronym: oksineukir

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 12, 2015
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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