Pain, PostoperativePhase 4epioksipanuNCT02573909
The Safety and Efficacy of Epidural Oxycodone
A Phase 4 study testing Oxycodone intravenously and Oxycodone epidurally in people with Pain, Postoperative, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
There are conflicting results in earlier studies concerning the safety and efficacy of epidural oxycodone. In a study by Bäcklund and colleagues, epidural oxycodone was as effective as intravenous oxycodone, so they did not recommend epidural use of oxycodone. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Oxycodone intravenously and Oxycodone epidurally
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2015to 31 Dec 2023
- Phase
- Phase 4
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned gynecological lower abdomen surgery with epidural pain treatment
- Informed consent obtained
Who cannot join
- Planned surgery under regional anesthesia
- contraindication to the study drug
- contraindication to the lumbar puncture
- Contraindication to oxycodone
- Pregnancy or lactation
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
There are conflicting results in earlier studies concerning the safety and efficacy of epidural oxycodone. In a study by Bäcklund and colleagues, epidural oxycodone was as effective as intravenous oxycodone, so they did not recommend epidural use of oxycodone. In another study, Yanagidate and Dohi reported that oxycodone was as effective in pain treatment with double dose compared to epidural morphine. In our previous study, epidural oxycodone provided safe and effective pain relief when compared to intravenous oxycodone.
In the present study, the aim was to compare the efficacy and safety of epidural or intravenous oxycodone in patients undergoing elective gynecological surgery with planned epidural pain treatment.
- Conditions
- Pain, Postoperative
- Being tested
- Oxycodone intravenously, Oxycodone epidurally
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone intravenouslyDrug
Also called oxycodoneIV
Oxycodone intravenously 0,1mg/kg
Oxycodone epidurallyDrug
Also called oxycodoneEpid
Oxycodone 0,1 mg epidurally
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone intravenously | Experimental | Oxycodone 0,1 mg/kg IV Receives: Drug: Oxycodone epidurally |
| Oxycodone epidurally | Experimental | Oxycodone 0,1 mg/kg epidurally Receives: Drug: Oxycodone intravenously |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of rescue medicine
The amount of rescue pain medication given after study drug administration up to four hours
Measured: from zero hours up to four hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start1 Jan 2015
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Admescope Ltd
- Responsible party
- Principal investigator, Merja Kokki, Kuopio University Hospital
- Investigators
- Merja Kokki, PhD, Principal investigator, Kuopio University Hospital, Kuopio, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02573909
- Sponsor's protocol ID
- KUH2014-004313-82
- Acronym
- epioksipanu
- Status last verified
- Mar 2023
- First submitted
- 8 Oct 2015
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Epidural Oxycodone
- ClinicalTrials.gov ID
- NCT02573909
- Acronym / sponsor ID
- epioksipanu / KUH2014-004313-82
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Admescope Ltd
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Oct 2015 (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.
There are conflicting results in earlier studies concerning the safety and efficacy of epidural oxycodone. In a study by Bäcklund and colleagues, epidural oxycodone was as effective as intravenous oxycodone, so they did not recommend epidural use of oxycodone. In another study, Yanagidate and Dohi reported that oxycodone was as effective in pain treatment with double dose compared to epidural morphine. In our previous study, epidural oxycodone provided safe and effective pain relief when compared to intravenous oxycodone.
In the present study, the aim was to compare the efficacy and safety of epidural or intravenous oxycodone in patients undergoing elective gynecological surgery with planned epidural pain treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone intravenously | Experimental | Drug: Oxycodone epidurallyOxycodone 0,1 mg/kg IV |
| Oxycodone epidurally | Experimental | Drug: Oxycodone intravenouslyOxycodone 0,1 mg/kg epidurally |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planned gynecological lower abdomen surgery with epidural pain treatment
- Informed consent obtained
Key exclusion criteria (6 listed)
- Planned surgery under regional anesthesia
- contraindication to the study drug
- contraindication to the lumbar puncture
- Contraindication to oxycodone
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone intravenouslyAlso: oxycodoneIVOxycodone intravenously 0,1mg/kg | Drug | Oxycodone epidurally |
| Oxycodone epidurallyAlso: oxycodoneEpidOxycodone 0,1 mg epidurally | Drug | Oxycodone intravenously |
Primary outcome
amount of rescue medicine
Time frame: from zero hours up to four hours
The amount of rescue pain medication given after study drug administration up to four hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Merja Kokki, PhD principal investigator
Kuopio University Hospital, Kuopio, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone intravenously and Oxycodone epidurally in people with Pain, Postoperative, run by Kuopio University Hospital at 1 site in Finland.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. 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 Finland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
amount of rescue medicine (time frame: from zero hours up to four hours). 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 16 Mar 2023.