Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section

NCT02571881 | Unknown Phase 4

• 1 other identifier: KUH01-07-2012
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation; Pain, Postoperative

Keywords

constipation; oxycodone; caesarean section

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Oxycodone

ACTIVE COMPARATOR

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

Procedure: Caesarean section; Drug: Oxycodone

Oxycodone-naloxone

EXPERIMENTAL

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

Procedure: Caesarean section; Drug: oxycodone-naloxone

Interventions

Caesarean section PROCEDURE

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

Oxycodone; Oxycodone-naloxone

Oxycodone DRUG

Oxycodone

oxycodone-naloxone DRUG

Oxycodone-naloxone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuopio University Hospital: lead
• Admescope Ltd: collaborator

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70029, Finland

Location

MeSH Terms

Conditions

Constipation; Pain, Postoperative

Interventions

Cesarean Section; Oxycodone; oxycodone naloxone combination

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Merja Kokki, MD, PhD

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 8, 2015
• Study Start: October 1, 2012
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

FI (1)