Constipation, Pain, Postoperative
Conditions
Keywords
constipation, oxycodone, caesarean section
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.
Interventions
PROCEDURECaesarean section
After caesarean section oxycodone or oxycodone-naloxone prolonged release tablet twice a day is started for pain medication
DRUGOxycodone
Sponsors
Admescope Ltd
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Finland
Outcome results
None listed