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Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section (oksisektio)

Primary Purpose

Constipation, Pain, Postoperative

Status
Active
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Caesarean section
Oxycodone
oxycodone-naloxone
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, oxycodone, caesarean section

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • • elective caesarean section in spinal anaesthesia

    • normal full term single pregnancy
    • age 18 years or more
    • BMI 20 - 35 kg/m2
    • written informed consent obtained

Exclusion Criteria:

  • • not normal or full term pregnancy

    • age less than 18 years
    • allergy to study drugs
    • substance misuse other contraindication to used study drugs no informed consent

Sites / Locations

  • Kuopio University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Oxycodone

Oxycodone-naloxone

Arm Description

Oxycodone 10 mg prolonged release tablet twice a day after caesarean section

Oxycodone-naloxone 10/5 mg prolonged release tablet twice a day after caesarean section

Outcomes

Primary Outcome Measures

Number of patients with opioid induced bowel dysfunction assessed with bowel function index

Secondary Outcome Measures

Oxycodone concentrations in maternal plasma

Full Information

First Posted
October 6, 2015
Last Updated
March 14, 2023
Sponsor
Kuopio University Hospital
Collaborators
Admescope Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02571881
Brief Title
Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section
Acronym
oksisektio
Official Title
Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2012 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Constipation is common in pregnant women. Surgery, anaesthesia and opioid analgesics may further impair bowel function. The aim of the present study was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced bowel dysfunction in patients undergoing caesarean section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Pain, Postoperative
Keywords
constipation, oxycodone, caesarean section

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Oxycodone
Arm Type
Active Comparator
Arm Description
Oxycodone 10 mg prolonged release tablet twice a day after caesarean section
Arm Title
Oxycodone-naloxone
Arm Type
Experimental
Arm Description
Oxycodone-naloxone 10/5 mg prolonged release tablet twice a day after caesarean section
Intervention Type
Procedure
Intervention Name(s)
Caesarean section
Intervention Description
After caesarean section oxycodone or oxycodone-naloxone prolonged release tablet twice a day is started for pain medication
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Type
Drug
Intervention Name(s)
oxycodone-naloxone
Primary Outcome Measure Information:
Title
Number of patients with opioid induced bowel dysfunction assessed with bowel function index
Time Frame
time from the first drug intake up to three weeks postoperatively
Secondary Outcome Measure Information:
Title
Oxycodone concentrations in maternal plasma
Time Frame
time before the first drug intake to the day when patient leaves the hospital up to maximum of seven days postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • elective caesarean section in spinal anaesthesia normal full term single pregnancy age 18 years or more BMI 20 - 35 kg/m2 written informed consent obtained Exclusion Criteria: • not normal or full term pregnancy age less than 18 years allergy to study drugs substance misuse other contraindication to used study drugs 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

Plan to Share IPD
Undecided

Learn more about this trial

Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section

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