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

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ClinicalTrials.gov Identifier: NCT02571881
Recruitment Status : Unknown
Verified March 2017 by Merja Kokki, Kuopio University Hospital.
Recruitment status was:  Recruiting
First Posted : October 8, 2015
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
Admescope Ltd
Information provided by (Responsible Party):
Merja Kokki, Kuopio University Hospital

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.

Condition or disease Intervention/treatment Phase
Constipation Pain, Postoperative Procedure: Caesarean section Drug: Oxycodone Drug: oxycodone-naloxone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section
Study Start Date : October 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Oxycodone
Oxycodone 10 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
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



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571881


Contacts
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Contact: Merja Kokki, MD, PhD +358447174764 merja.kokki@kuh.fi

Locations
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Finland
Kuopio University Hospital Recruiting
Kuopio, Northern savo, Finland, 70029
Contact: Merja Kokki, PhD    +358447174764      
Sponsors and Collaborators
Kuopio University Hospital
Admescope Ltd
Investigators
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Principal Investigator: Merja Kokki, MD, PhD Kuopio University Hospital

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Responsible Party: Merja Kokki, MD, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT02571881     History of Changes
Other Study ID Numbers: KUH01-07-2012
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Merja Kokki, Kuopio University Hospital:
constipation
oxycodone
caesarean section

Additional relevant MeSH terms:
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Oxycodone
Constipation
Pain, Postoperative
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Gastrointestinal Diseases
Digestive System Diseases
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists