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

Analgesic Adverse Reaction Clinical Trial

Official title:

Gastrointestinal Uptake of Oxycodone After Caesarean Section in Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717637
• Other study ID #: 2014/1781
• Status: Completed
• Phase: N/A
• First received: March 15, 2016
• Last updated: January 11, 2018
• Start date: February 2016
• Est. completion date: April 2017

Study information

• Verified date: January 2018
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesic Adverse Reaction
• Cesarean Delivery Affecting Newborn

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Nordbyhagen	Akershus

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects	nausea and vomiting, other side effects	1,2 and 6 hourd after administration
Primary	level of oxycodone in serum		1 hour after administration
Primary	level of oxycodone in serum		2 hours after administration
Primary	level of oxycodone in serum		6 hours after administration
Secondary	level of pain	NRS scale 0-10	0, 1, 2, and 6 hours after administration