Oxycodone in Serum After Postoperative Oral Oxycodone in Caesarean Sections Under Spinal Anesthesia

January 11, 2018 updated by: Vegard Dahl, University Hospital, Akershus

Gastrointestinal Uptake of Oxycodone After Caesarean Section in Spinal Anesthesia

All patients undergoing an elective caesarean section under spinal anesthesia will, according to the hospital routines, receive 10 mg oxycodone slow-release tablet when arriving at our postoperative care unit (PACU). Blood samples will be taken at 0 hour, 1 hour, 2 and 6 hours after administration in order to investigate bioavailability.

Study Overview

Status

Completed

Conditions

Detailed Description

After written informed consent, blood samples will be taken before administration, after 1 hour, 2 hours and 6 hours. Need of rescue analgesia (morphine iv) and level of pain, as well as side effects will be registered

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Nordbyhagen, Akershus, Norway, 1478
        • Akershus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with single fetus in cephalated position admitted for elective caesarean section in spinal anesthesia

Description

Inclusion Criteria: Healthy women > 18 years old, with one healthy fetus scheduled for a elective caesarean section in spinal anesthesia, read and signed informed consent

-

Exclusion Criteria:

  • Known intolerability to oxycodone. Previous use of opioids. Hight < 150 cm, preconceptual BMI > 35. ASA > 2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
level of oxycodone in serum
Time Frame: 1 hour after administration
1 hour after administration
level of oxycodone in serum
Time Frame: 2 hours after administration
2 hours after administration
level of oxycodone in serum
Time Frame: 6 hours after administration
6 hours after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of pain
Time Frame: 0, 1, 2, and 6 hours after administration
NRS scale 0-10
0, 1, 2, and 6 hours after administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 1,2 and 6 hourd after administration
nausea and vomiting, other side effects
1,2 and 6 hourd after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Investigators

  • Principal Investigator: Vegard Dahl, PhD, Head of anesthesia dept

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014/1781

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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