Postoperative PainPhase 4NCT03199157
Fentanyl 12 Mcg Transdermal Patch For Postoperative Pain
A Phase 4 study testing Fentanyl transdermal patch in people with Postoperative Pain, run by Baskent University.
Trial summary
The investigators designed a prospective randomized study to investigate the effect of fentanyl 12 mcg transdermal patch on postoperative pain following unilateral, single-level laminectomy/discectomy. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Fentanyl transdermal patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2016
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between the ages of 20-70 years
- ASA physical status 1-2 patients undergoing single-level laminectomy/discectomy
Who cannot join
- A history of allergy to any study drugs
- History of opioid use, obstructive sleep apnea
- Any psychological disorders
- hepatic or renal failure
About this study
Official title: The Effect Of Fentanyl 12 Mcg Transdermal Patch On Postoperative Pain Following Unilateral, Single-Level Laminectomy/Discectomy: A Randomized, Controlled, Double-Blind Study
The investigators designed a prospective randomized study to investigate the effect of fentanyl 12 mcg transdermal patch on postoperative pain following unilateral, single-level laminectomy/discectomy.
- Conditions
- Postoperative Pain
- Being tested
- Fentanyl transdermal patch
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl transdermal patchDrug
Patients received fentanyl 12 mcg transdermal patch group 8 hours preoperatively and until 24 hours after the surgery
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl Group | Active comparator | Patients received the fentanyl 12 mcg transdermal patch (FG, n=38) 8 hours preoperatively and until 24 hours after the surgery Receives: Drug: Fentanyl transdermal patch |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating score for pain (NRS)
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study startMar 2015
- Primary completionSep 2016
- Study completionDec 2016
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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oya Yalcin Cok, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199157
- Sponsor's protocol ID
- KA14-66
- Status last verified
- Jun 2017
- First submitted
- 23 Jun 2017
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Fentanyl 12 Mcg Transdermal Patch On Postoperative Pain Following Unilateral, Single-Level Laminectomy/Discectomy: A Randomized, Controlled, Double-Blind Study
- ClinicalTrials.gov ID
- NCT03199157
- Acronym / sponsor ID
- KA14-66
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Jun 2017 (actual)
- 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 investigators designed a prospective randomized study to investigate the effect of fentanyl 12 mcg transdermal patch on postoperative pain following unilateral, single-level laminectomy/discectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl Group | Active comparator | Drug: Fentanyl transdermal patchPatients received the fentanyl 12 mcg transdermal patch (FG, n=38) 8 hours preoperatively and until 24 hours after the surgery |
| Control group | No intervention | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between the ages of 20-70 years
- ASA physical status 1-2 patients undergoing single-level laminectomy/discectomy
Key exclusion criteria (4 listed)
- A history of allergy to any study drugs
- History of opioid use, obstructive sleep apnea
- Any psychological disorders
- hepatic or renal failure
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 transdermal patchPatients received fentanyl 12 mcg transdermal patch group 8 hours preoperatively and until 24 hours after the surgery | Drug | Fentanyl Group |
Primary outcome
Numeric rating score for pain (NRS)
Time frame: Postoperative 24 hours
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 26 Jun 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl transdermal patch in people with Postoperative Pain, run by Baskent University.
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 4 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 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Numeric rating score for pain (NRS) (time frame: Postoperative 24 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 26 Jun 2017.