- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01348984
Study of Transdermal Fentanyl Patch to Treat Postoperative Pain in Total Knee Arthroplasty (TFP)
Transdermal Fentanyl Patch for Postoperative Analgesia in Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Khon Kaen, Thailand, 40002
- Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who were scheduled for TKA gave informed consent for inclusion
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: group 1
group 1 = transdermal fentanyl patch
|
TFP = transdermal fentanyl patch (50 microgram/hour)
Other Names:
|
Placebo Comparator: group 2
placebo patch
|
group 2 = placebo patch
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
intravenous morphine consumption
Time Frame: 48 hours
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain score
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thepakorn Sathitkarnmanee, MD, Faculty of Medicine, Khon Kaen University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
Other Study ID Numbers
- TFP TKA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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