NCT02717637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

March 15, 2016

Last Update Submit

January 11, 2018

Conditions

Analgesic Adverse ReactionCesarean Delivery Affecting Newborn

Keywords

oxycodone, caesarean, spinal anesthesia

Outcome Measures

Primary Outcomes (3)

  • level of oxycodone in serum

    1 hour after administration

  • level of oxycodone in serum

    2 hours after administration

  • level of oxycodone in serum

    6 hours after administration

Secondary Outcomes (1)

  • level of pain

    0, 1, 2, and 6 hours after administration

Other Outcomes (1)

  • Side effects

    1,2 and 6 hourd after administration

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with single fetus in cephalated position admitted for elective caesarean section in spinal anesthesia

You may not qualify if:

  • Known intolerability to oxycodone. Previous use of opioids. Hight \< 150 cm, preconceptual BMI \> 35. ASA \> 2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Nordbyhagen, Akershus, 1478, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum from blood

Study Officials

  • Vegard Dahl, PhD

    Head of anesthesia dept

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor 2

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 24, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

January 12, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)