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

Gastrointestinal Uptake of Oxycodone After Caesarean Section in Spinal Anesthesia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02717637

Enrollment

Registered

2016-03-24

Start date

2016-02-29

Completion date

2017-04-30

Last updated

2018-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesic Adverse Reaction, Cesarean Delivery Affecting Newborn

Keywords

oxycodone, caesarean, spinal anesthesia

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.

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
level of oxycodone in serum	1 hour after administration

Secondary

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

Other

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

Countries

Norway

Outcome results