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

Postoperative Pain Clinical Trial

— TFP  

Official title:

Transdermal Fentanyl Patch for Postoperative Analgesia in Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348984
• Other study ID #: TFP TKA
• Status: Completed
• Phase: Phase 4
• First received: May 4, 2011
• Last updated: May 5, 2011
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2010
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• transdermal fentanyl patch
TFP = transdermal fentanyl patch (50 microgram/hour)
• placebo patch
group 2 = placebo patch

Locations

Country	Name	City	State
Thailand	Srinagarind Hospital, Faculty of Medicine, Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intravenous morphine consumption		48 hours	Yes
Secondary	Pain score		48 hours	No