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

Sponsor
University Hospital, Akershus (Other)
Overall Status
Completed
CT.gov ID
NCT02717637
Collaborator
(none)
50
Enrollment
1
Location
14
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Gastrointestinal Uptake of Oxycodone After Caesarean Section in Spinal Anesthesia
    Actual Study Start Date :
    Feb 1, 2016
    Actual Primary Completion Date :
    Apr 1, 2017
    Actual Study Completion Date :
    Apr 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. level of oxycodone in serum [1 hour after administration]

    2. level of oxycodone in serum [2 hours after administration]

    3. level of oxycodone in serum [6 hours after administration]

    Secondary Outcome Measures

    1. level of pain [0, 1, 2, and 6 hours after administration]

      NRS scale 0-10

    Other Outcome Measures

    1. Side effects [1,2 and 6 hourd after administration]

      nausea and vomiting, other side effects

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Akershus University Hospital Nordbyhagen Akershus Norway 1478

    Sponsors and Collaborators

    • University Hospital, Akershus

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vegard Dahl, Professor 2, University Hospital, Akershus
    ClinicalTrials.gov Identifier:
    NCT02717637
    Other Study ID Numbers:
    • 2014/1781
    First Posted:
    Mar 24, 2016
    Last Update Posted:
    Jan 12, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Vegard Dahl, Professor 2, University Hospital, Akershus
    oxycodone, caesarean, spinal anesthesia

    Study Results

    No Results Posted as of Jan 12, 2018