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Trial record 84 of 663 for:    OXYCODONE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02717637
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : January 12, 2018
Information provided by (Responsible Party):
Vegard Dahl, University Hospital, Akershus

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
Analgesic Adverse Reaction Cesarean Delivery Affecting Newborn

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

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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 : February 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Primary Outcome Measures :
  1. level of oxycodone in serum [ Time Frame: 1 hour after administration ]
  2. level of oxycodone in serum [ Time Frame: 2 hours after administration ]
  3. level of oxycodone in serum [ Time Frame: 6 hours after administration ]

Secondary Outcome Measures :
  1. level of pain [ Time Frame: 0, 1, 2, and 6 hours after administration ]
    NRS scale 0-10

Other Outcome Measures:
  1. Side effects [ Time Frame: 1,2 and 6 hourd after administration ]
    nausea and vomiting, other side effects

Biospecimen Retention:   Samples Without DNA
Serum from blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with single fetus in cephalated position admitted for elective caesarean section in spinal anesthesia

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02717637

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Akershus University Hospital
Nordbyhagen, Akershus, Norway, 1478
Sponsors and Collaborators
University Hospital, Akershus
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Principal Investigator: Vegard Dahl, PhD Head of anesthesia dept

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Responsible Party: Vegard Dahl, Professor 2, University Hospital, Akershus Identifier: NCT02717637     History of Changes
Other Study ID Numbers: 2014/1781
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vegard Dahl, University Hospital, Akershus:
oxycodone, caesarean, spinal anesthesia
Additional relevant MeSH terms:
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Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents