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

Khon Kaen University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: placebo patch; Drug: transdermal fentanyl patch

Study type: Interventional

Funder types: Other

Identifiers

NCT01348984

TFP TKA

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

group 1

Active Comparator group

Description:

group 1 = transdermal fentanyl patch

Treatment:

Drug: transdermal fentanyl patch

group 2

Placebo Comparator group

Description:

placebo patch

Treatment:

Drug: placebo patch