Back to resultsOpioid 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
About this trial
This is an interventional treatment trial for Constipation focused on measuring constipation, oxycodone, caesarean section
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
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
NCT ID
NCT02571881
First Posted
October 6, 2015
Last Updated
March 14, 2023
Sponsor
Kuopio University Hospital
Collaborators
Admescope Ltd
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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