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Trial record 65 of 475 for:    CANDOX OR CAREXIL OR OXYCONTIN OR OXYNORM OR RELTEBON OR LEVERAXO OR LONGTEC OR OXAYDO OR SHORTEC OR OXELTRA OR OXYLAN OR ZOMESTINE OR OXYCODONE HYDROCHLORIDE OR ROXYBOND OR ROXICODONE OR LYNLOR OR OXECTA OR ABTARD OR DOLOCODON PR

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

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ClinicalTrials.gov Identifier: NCT02717637
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : January 12, 2018
Sponsor:
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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02717637


Locations
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Norway
Akershus University Hospital
Nordbyhagen, Akershus, Norway, 1478
Sponsors and Collaborators
University Hospital, Akershus
Investigators
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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
ClinicalTrials.gov 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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Anesthetics
Oxycodone
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents