Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery

Phase 4

Completed

• Conditions: Constipation
• Interventions: Drug: oxycodone-naloxone; Drug: Oxycodone

• Registration Number: NCT02573922
• Lead Sponsor: Kuopio University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-10
• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-10-09
• Last Update Submitted: 2015-10-09
• Study First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone-naloxone	oxycodone-naloxone	Oxycodone-naloxone prolonged release tablet twice a day
Oxycodone	Oxycodone	Oxycodone prolonged release tablet twice a day

Primary Outcome Measures

Name	Time	Method
opioid induced constipation	from the surgery up to 21 days	Opioid induced constipation was assessed with bowel function index

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Northern Savo, Finland