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

Completed

• Conditions: Analgesic Adverse Reaction; Cesarean Delivery Affecting Newborn

• Registration Number: NCT02717637
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-18
• Study First Posted: 2016-03-24
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
level of oxycodone in serum	6 hours after administration

Secondary Outcome Measures

Name	Time	Method
level of pain	0, 1, 2, and 6 hours after administration	NRS scale 0-10

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Nordbyhagen, Akershus, Norway