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

March 14, 2023 updated by: Merja Kokki, Kuopio University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
    • Northern Savo
      • Kuopio, Northern Savo, Finland, 70029
        • Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxycodone
Oxycodone 10 mg prolonged release tablet twice a day after caesarean section
Drug: Oxycodone
Procedure: Caesarean section
After caesarean section oxycodone or oxycodone-naloxone prolonged release tablet twice a day is started for pain medication
Experimental: Oxycodone-naloxone
Oxycodone-naloxone 10/5 mg prolonged release tablet twice a day after caesarean section
Procedure: Caesarean section
After caesarean section oxycodone or oxycodone-naloxone prolonged release tablet twice a day is started for pain medication
Drug: oxycodone-naloxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
time from the first drug intake up to three weeks postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
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
time before the first drug intake to the day when patient leaves the hospital up to maximum of seven days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Collaborators

Admescope Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2012

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 6, 2015

First Submitted That Met QC Criteria

October 7, 2015

First Posted (Estimate)

October 8, 2015

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH01-07-2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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