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

Kuopio University Hospital

Status and phase: Active, not recruiting; Phase 4

Conditions: Pain, Postoperative; Constipation

Treatments: Drug: Oxycodone; Procedure: Caesarean section; Drug: oxycodone-naloxone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02571881

KUH01-07-2012

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Oxycodone

Active Comparator group

Description:

Oxycodone 10 mg prolonged release tablet twice a day after caesarean section

Treatment:

Procedure: Caesarean section

Drug: Oxycodone

Oxycodone-naloxone

Experimental group

Description:

Oxycodone-naloxone 10/5 mg prolonged release tablet twice a day after caesarean section

Treatment:

Procedure: Caesarean section

Drug: oxycodone-naloxone