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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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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

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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group 1

group 1 = transdermal fentanyl patch

Group Type ACTIVE_COMPARATOR

transdermal fentanyl patch

Intervention Type DRUG

TFP = transdermal fentanyl patch (50 microgram/hour)

group 2

placebo patch

Group Type PLACEBO_COMPARATOR

placebo patch

Intervention Type DRUG

group 2 = placebo patch

Interventions

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transdermal fentanyl patch

TFP = transdermal fentanyl patch (50 microgram/hour)

Intervention Type DRUG

placebo patch

group 2 = placebo patch

Intervention Type DRUG

Other Intervention Names

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Duragesic Duragesic

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No