Postoperative PainPhase 4NCT01666379
Pain Management After Forefoot Surgery
A Phase 4 study testing Fentanyl in people with Postoperative Pain, run by Turku University Hospital at 1 site in Finland.
Trial summary
The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol in treatment of postoperative pain after hallux valgus or hallux rigidus surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Fentanyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2009to Nov 2010
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral hallux valgus or hallux rigidus surgery
- 18-75 yrs old
- ASA I-III
Who cannot join
- previous history of intolerance to the study drug
- history of alcoholism
- drug abuse
- psychological or other emotional problems that are likely to invalidate informed consent
- sleep apnoea
- BMI ≥ 35 kg/m2
Trial locations and contacts
1 site in 1 country.
Finland1 site
The Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Management of Turku University Hospital
Turku
About this study
The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol in treatment of postoperative pain after hallux valgus or hallux rigidus surgery.
- Conditions
- Postoperative Pain
- Being tested
- Fentanyl
- Keywords
- Hallux valgus, Forefoot, transdermal fentanyl
- Medical subject headings
- Pain, Postoperative, Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Experimental | Not described Receives: Drug: Fentanyl |
| placebo | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of rescue opioid
Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure
Measured: on the 1st postoperative day
Secondary outcomes (1)
Pain on a numerical scale
The adverse effects were evaluated but the evaluation was not the first or secondary outcome measure
Measured: on the 1st postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Riika Merivirta, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666379
- Sponsor's protocol ID
- ForefootFenta vs.2
- Status last verified
- Aug 2012
- First submitted
- 19 Jul 2012
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management After Forefoot Surgery
- ClinicalTrials.gov ID
- NCT01666379
- Acronym / sponsor ID
- ForefootFenta vs.2
- Conditions
- Postoperative Pain
- Keywords
- Hallux valgus, Forefoot, transdermal fentanyl
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 16 Aug 2012 (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.
The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol in treatment of postoperative pain after hallux valgus or hallux rigidus surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Experimental | Drug: Fentanyl |
| placebo | Placebo comparator | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- unilateral hallux valgus or hallux rigidus surgery
- 18-75 yrs old
- ASA I-III
Key exclusion criteria (6 listed)
- previous history of intolerance to the study drug
- history of alcoholism
- drug abuse
- psychological or other emotional problems that are likely to invalidate informed consent
- sleep apnoea
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 |
|---|---|---|
| Fentanyl | Drug | Fentanyl |
Primary outcome
Consumption of rescue opioid
Time frame: on the 1st postoperative day
Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure
1 secondary outcome
Pain on a numerical scale
Time frame: on the 1st postoperative day
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 16 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fentanyl in people with Postoperative Pain, run by Turku 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 3 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: finished, as of the sponsor's last update on 16 Aug 2012. 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. Some participants in this study may receive a placebo. 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?
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?
Consumption of rescue opioid (time frame: on the 1st postoperative day). 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 Aug 2012.