Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section

Phase 4

Active, not recruiting

• Conditions: Pain, Postoperative; Constipation
• Interventions: Procedure: Caesarean section; Drug: oxycodone-naloxone; Drug: Oxycodone

• Registration Number: NCT02571881
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-16
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 57

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone	Caesarean section	Oxycodone 10 mg prolonged release tablet twice a day after caesarean section
Oxycodone-naloxone	Caesarean section	Oxycodone-naloxone 10/5 mg prolonged release tablet twice a day after caesarean section
Oxycodone-naloxone	oxycodone-naloxone	Oxycodone-naloxone 10/5 mg prolonged release tablet twice a day after caesarean section
Oxycodone	Oxycodone	Oxycodone 10 mg prolonged release tablet twice a day after caesarean section

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kuopio University Hospital; 🇫🇮 Kuopio, Northern Savo, Finland