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

This study has been completed.
Sponsor:
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT01348984
First received: May 4, 2011
Last updated: May 5, 2011
Last verified: February 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Postoperative Pain
 Drug: transdermal fentanyl patch
Drug: placebo patch
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transdermal Fentanyl Patch for Postoperative Analgesia in Total Knee Arthroplasty

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • intravenous morphine consumption [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain score [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Thepakorn Sathitkarnmanee, Faculty of Medicine, Khon Kaen University
ClinicalTrials.gov Identifier: NCT01348984     History of Changes
Other Study ID Numbers: TFP TKA
Study First Received: May 4, 2011
Last Updated: May 5, 2011
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

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

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

ClinicalTrials.gov processed this record on May 16, 2013