Postoperative PainPhase 4TFPNCT01348984
Study of Transdermal Fentanyl Patch to Treat Postoperative Pain in Total Knee Arthroplasty
A Phase 4 study testing transdermal fentanyl patch in people with Postoperative Pain, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether transdermal fentanyl patch Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- transdermal fentanyl patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2010to Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were scheduled for TKA gave informed consent for inclusion
Who cannot join
- ASA class 3-4
- Known allergy to any of the drugs to be used, eg. TFPs ,MO
- History of substance or alcohol abuse, and tolerance or dependence on opioids
- Can not use PCA
- Contraindication for spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
About this study
Official title: Transdermal Fentanyl Patch for Postoperative Analgesia in Total Knee Arthroplasty
The purpose of this study is to determine whether transdermal fentanyl patch
Read the detailed description
Total knee arthroplasty (TKA) has severe postoperative pain that prevents mobilization of patient. The best standard analgesia regimen is patient-control analgesia (PCA) which requires a PCA pump that is expensive.
Transdermal fentanyl patch (TFP)(50 mcg/hr) can release fentanyl into blood circulation at rate 50 mcg/hr for three days. It has slow onset of about 12-14 hours, so it's used to treat chronic pain, not popular for a cure of pain. If the investigators apply TFP at appropriate times, i.e. 12-14 hours before surgery, it may be used to treat acute postoperative pain.
If it can give good analgesia for TKA, it can replace PCA. The benefit is that it is much cheaper and more convenient.
- Conditions
- Postoperative Pain
- Being tested
- transdermal fentanyl patch, placebo patch
- Keywords
- postoperative, pain score, morphine consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transdermal fentanyl patchDrug
Also called Duragesic
TFP = transdermal fentanyl patch (50 microgram/hour)
placebo patchDrug
Also called Duragesic
group 2 = placebo patch
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Active comparator | group 1 = transdermal fentanyl patch Receives: Drug: transdermal fentanyl patch |
| group 2 | Placebo comparator | placebo patch Receives: Drug: placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
intravenous morphine consumption
Measured: 48 hours
Secondary outcomes (1)
Pain score
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2011 (estimated)
- Study startApr 2010
- Primary completionOct 2010
- Study completionDec 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Investigators
- Thepakorn Sathitkarnmanee, MD, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348984
- Sponsor's protocol ID
- TFP TKA
- Acronym
- TFP
- Status last verified
- Feb 2010
- First submitted
- 4 May 2011
- Last updated
- 6 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Fentanyl Patch for Postoperative Analgesia in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01348984
- Acronym / sponsor ID
- TFP / TFP TKA
- Conditions
- Postoperative Pain
- Keywords
- postoperative, pain score, morphine consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 6 May 2011 (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 is to determine whether transdermal fentanyl patch
Detailed description
Total knee arthroplasty (TKA) has severe postoperative pain that prevents mobilization of patient. The best standard analgesia regimen is patient-control analgesia (PCA) which requires a PCA pump that is expensive.
Transdermal fentanyl patch (TFP)(50 mcg/hr) can release fentanyl into blood circulation at rate 50 mcg/hr for three days. It has slow onset of about 12-14 hours, so it's used to treat chronic pain, not popular for a cure of pain. If the investigators apply TFP at appropriate times, i.e. 12-14 hours before surgery, it may be used to treat acute postoperative pain.
If it can give good analgesia for TKA, it can replace PCA. The benefit is that it is much cheaper and more convenient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Active comparator | Drug: transdermal fentanyl patchgroup 1 = transdermal fentanyl patch |
| group 2 | Placebo comparator | Drug: placebo patchplacebo patch |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were scheduled for TKA gave informed consent for inclusion
Key exclusion criteria (5 listed)
- ASA class 3-4
- Known allergy to any of the drugs to be used, eg. TFPs ,MO
- History of substance or alcohol abuse, and tolerance or dependence on opioids
- Can not use PCA
- Contraindication for spinal anesthesia
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 |
|---|---|---|
| transdermal fentanyl patchAlso: DuragesicTFP = transdermal fentanyl patch (50 microgram/hour) | Drug | group 1 |
| placebo patchAlso: Duragesicgroup 2 = placebo patch | Drug | group 2 |
Primary outcome
intravenous morphine consumption
Time frame: 48 hours
1 secondary outcome
Pain score
Time frame: 48 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 6 May 2011.
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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.
Thepakorn Sathitkarnmanee, MD principal investigator
Khon Kaen University
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 transdermal fentanyl patch in people with Postoperative Pain, run by Khon Kaen University at 1 site in Thailand.
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 1 inclusion and 5 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 6 May 2011. 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 Thailand. 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?
intravenous morphine consumption (time frame: 48 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 6 May 2011; AzTrials last refreshed its copy on 7 Nov 2026.