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

Primary Purpose

Constipation

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
oxycodone-naloxone
Oxycodone
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation, opioid, Oxycodone, Oxycodone-naloxone, spine surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oxycodone-naloxone

Oxycodone

Arm Description

Oxycodone-naloxone prolonged release tablet twice a day

Oxycodone prolonged release tablet twice a day

Outcomes

Primary Outcome Measures

opioid induced constipation
Opioid induced constipation was assessed with bowel function index

Secondary Outcome Measures

Full Information

First Posted
October 9, 2015
Last Updated
October 9, 2015
Sponsor
Kuopio University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02573922
Brief Title
Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery
Acronym
oksineukir
Official Title
Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, opioid, Oxycodone, Oxycodone-naloxone, spine surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone-naloxone
Arm Type
Experimental
Arm Description
Oxycodone-naloxone prolonged release tablet twice a day
Arm Title
Oxycodone
Arm Type
Active Comparator
Arm Description
Oxycodone prolonged release tablet twice a day
Intervention Type
Drug
Intervention Name(s)
oxycodone-naloxone
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Primary Outcome Measure Information:
Title
opioid induced constipation
Description
Opioid induced constipation was assessed with bowel function index
Time Frame
from the surgery up to 21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merja Kokki, MD, PhD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
State/Province
Northern Savo
ZIP/Postal Code
70029
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30073471
Citation
Kuronen M, Kokki H, Nyyssonen T, Savolainen S, Kokki M. Life satisfaction and pain interference in spine surgery patients before and after surgery: comparison between on-opioid and opioid-naive patients. Qual Life Res. 2018 Nov;27(11):3013-3020. doi: 10.1007/s11136-018-1961-x. Epub 2018 Aug 2.
Results Reference
derived
PubMed Identifier
27921252
Citation
Kokki M, Kuronen M, Naaranlahti T, Nyyssonen T, Pikkarainen I, Savolainen S, Kokki H. Opioid-Induced Bowel Dysfunction in Patients Undergoing Spine Surgery: Comparison of Oxycodone and Oxycodone-Naloxone Treatment. Adv Ther. 2017 Jan;34(1):236-251. doi: 10.1007/s12325-016-0456-9. Epub 2016 Dec 5.
Results Reference
derived

Learn more about this trial

Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery

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