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NCT02571881 Clinical Trial

Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section

Pain, Postoperative Clinical Trial

— oksisektio  

Official title:
Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02571881
Other study ID # KUH01-07-2012
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date October 2012
Est. completion date December 2023

Study information
Verified date March 2023
Source Kuopio University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 57
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Caesarean section
After caesarean section oxycodone or oxycodone-naloxone prolonged release tablet twice a day is started for pain medication
Drug:
• Oxycodone

• oxycodone-naloxone

Locations
Country Name City State
Finland Kuopio University Hospital Kuopio Northern Savo

Sponsors (2)
Lead Sponsor Collaborator
Kuopio University Hospital Admescope Ltd

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with opioid induced bowel dysfunction assessed with bowel function index time from the first drug intake up to three weeks postoperatively
Secondary Oxycodone concentrations in maternal plasma 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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