Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02573922

Acronym

oksineukir

Enrollment

180

Registered

2015-10-12

Start date

2012-05-31

Completion date

2014-12-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

constipation, opioid, Oxycodone, Oxycodone-naloxone, spine surgery

Brief summary

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.

Interventions

DRUGoxycodone-naloxone

DRUGOxycodone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
opioid induced constipation	from the surgery up to 21 days	Opioid induced constipation was assessed with bowel function index

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026