Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section

Kuopio University Hospital57 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Constipation Pain, Postoperative

Interventions

Caesarean sectionPROCEDURE

After caesarean section oxycodone or oxycodone-naloxone prolonged release tablet twice a day is started for pain medication

OxycodoneDRUG

oxycodone-naloxoneDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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