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Clinical Trials/NCT01348984
NCT01348984
Completed
Phase 4

Transdermal Fentanyl Patch for Postoperative Analgesia in Total Knee Arthroplasty

Khon Kaen University1 site in 1 country40 target enrollmentApril 2010

Overview

Phase
Phase 4
Intervention
transdermal fentanyl patch
Conditions
Postoperative Pain
Sponsor
Khon Kaen University
Enrollment
40
Locations
1
Primary Endpoint
intravenous morphine consumption
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
December 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Arms & Interventions

group 1

group 1 = transdermal fentanyl patch

Intervention: transdermal fentanyl patch

group 2

placebo patch

Intervention: placebo patch

Outcomes

Primary Outcomes

intravenous morphine consumption

Time Frame: 48 hours

Secondary Outcomes

  • Pain score(48 hours)

Study Sites (1)

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