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Completed

NCT Number: NCT01348984

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

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdermal fentanyl patch

Drug

TFP = transdermal fentanyl patch (50 microgram/hour)

Other names: Duragesic

Placebo Patch

Drug

group 2 = placebo patch

Other names: Duragesic

Primary outcomes

  1. intravenous morphine consumption

    Time frame: 48 hours

Secondary outcomes

  1. Pain score

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

Transdermal Fentanyl Patch for Postoperative Analgesia in Total Knee Arthroplasty

Acronym: TFP

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 6, 2011
Registry last updated
May 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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