Analgesic Adverse ReactionNCT02717637
Oxycodone in Serum After Postoperative Oral Oxycodone in Caesarean Sections Under Spinal Anesthesia
An observational study of Analgesic Adverse Reaction and Cesarean Delivery Affecting Newborn, run by University Hospital, Akershus at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Analgesic Adverse Reaction, Cesarean Delivery Affecting Newborn
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2016to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with single fetus in cephalated position admitted for elective caesarean section in spinal anesthesia
Who may be able to join
None listed.
Who cannot join
- Known intolerability to oxycodone. Previous use of opioids. Hight < 150 cm, preconceptual BMI > 35. ASA > 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastrointestinal Uptake of Oxycodone After Caesarean Section in 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.
Read the 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
- Keywords
- oxycodone, caesarean, spinal anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
level of oxycodone in serum
Measured: 1 hour after administration
level of oxycodone in serum
Measured: 2 hours after administration
level of oxycodone in serum
Measured: 6 hours after administration
Secondary outcomes (1)
level of pain
NRS scale 0-10
Measured: 0, 1, 2, and 6 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesic Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vegard Dahl, University Hospital, Akershus
- Investigators
- Vegard Dahl, PhD, Principal investigator, Head of anesthesia dept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717637
- Sponsor's protocol ID
- 2014/1781
- Status last verified
- Jan 2018
- First submitted
- 15 Mar 2016
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Uptake of Oxycodone After Caesarean Section in Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02717637
- Acronym / sponsor ID
- 2014/1781
- Keywords
- oxycodone, caesarean, spinal anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 24 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with single fetus in cephalated position admitted for elective caesarean section in spinal anesthesia
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Known intolerability to oxycodone. Previous use of opioids. Hight < 150 cm, preconceptual BMI > 35. ASA > 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
level of oxycodone in serum
Time frame: 1 hour after administration
level of oxycodone in serum
Time frame: 2 hours after administration
level of oxycodone in serum
Time frame: 6 hours after administration
1 secondary outcome
level of pain
Time frame: 0, 1, 2, and 6 hours after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vegard Dahl, PhD principal investigator
Head of anesthesia dept
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesic Adverse Reaction and Cesarean Delivery Affecting Newborn, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of oxycodone in serum (time frame: 1 hour after administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2018.