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Study of Transdermal Fentanyl Patch to Treat Postoperative Pain in Total Knee Arthroplasty (TFP)

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ClinicalTrials.gov Identifier: NCT01348984
Recruitment Status : Completed
First Posted : May 6, 2011
Last Update Posted : May 6, 2011
Sponsor:
Information provided by:
Khon Kaen University

Brief Summary:
The purpose of this study is to determine whether transdermal fentanyl patch

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: transdermal fentanyl patch Drug: placebo patch Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transdermal Fentanyl Patch for Postoperative Analgesia in Total Knee Arthroplasty
Study Start Date : April 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: group 1
group 1 = transdermal fentanyl patch
Drug: transdermal fentanyl patch
TFP = transdermal fentanyl patch (50 microgram/hour)
Other Name: Duragesic
Placebo Comparator: group 2
placebo patch
Drug: placebo patch
group 2 = placebo patch
Other Name: Duragesic



Primary Outcome Measures :
  1. intravenous morphine consumption [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Pain score [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348984


Locations
Thailand
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Thepakorn Sathitkarnmanee, MD Faculty of Medicine, Khon Kaen University

Responsible Party: Thepakorn Sathitkarnmanee, Faculty of Medicine, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01348984     History of Changes
Other Study ID Numbers: TFP TKA
First Posted: May 6, 2011    Key Record Dates
Last Update Posted: May 6, 2011
Last Verified: February 2010

Keywords provided by Khon Kaen University:
postoperative
pain score
morphine consumption

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics