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OpenTrials
Completed

NCT Number: NCT02717637

Oxycodone in Serum After Postoperative Oral Oxycodone in Caesarean Sections Under 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.

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Key information

Conditions

Analgesic Adverse Reaction Cesarean Delivery Affecting Newborn

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Akershus University Hospital

Nordbyhagen, Akershus, 1478, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  1. level of pain

    Time frame: 0, 1, 2, and 6 hours after administration

    NRS scale 0-10

Other outcomes

  1. Side effects

    Time frame: 1,2 and 6 hourd after administration

    nausea and vomiting, other side effects

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Official study title

Gastrointestinal Uptake of Oxycodone After Caesarean Section in Spinal Anesthesia

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2016
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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